Medical Device Business Magazine-Medical Device News and Articles | Massive Equipment

Summary of first-level recalls in March: 10 second-level recalls: 183

Recall manufacturer, release date, product name/product, reason for recall

MCKESSON TECHNOLOGIES INC. Mar-05-2014 McKesson Anesthesia Care System – McKesson Anesthesia CareProduct Usage: McKesson Anesthesia Care System is a computer-based system that collects; processes; and records data through manual input and from a monitor connected to the patient ; For example, in an operating room environment. The system provides clinical decision support by actively communicating alerts of potential adverse drug events during the pre-anaesthesia assessment and at the point of care. When an anesthesia provider decides to perform a patient assessment, the system usually instructs in an anesthesia environment; generates paper and/or electronic records of the patient's anesthesia; and records care. When a case is recalled in the Anesthesia Care Record (ACR), the patient case data does not match the patient data because it includes data from another case.

Philips Respironics; Inc. Mar-06-2014 Philips Respironics Trilogy 100; Trilogy 200; Trilogy 202-Trilogy Ventilator The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for individuals who require mechanical ventilation. Trilogy 100 is suitable for children to adults weighing at least 5 kg (11 lbs). The device is intended for use in homes; institutions/hospitals; and portable applications such as wheelchairs and gurneys; and can be used for invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for individuals who require mechanical ventilation. Trilogy 200 is suitable for children to adults weighing at least 5 kg (11 lbs). The device is intended for use in homes; institutions/hospitals; and portable applications such as wheelchairs and gurneys; and can be used for invasive and non-invasive ventilation. Trilogy 202 Intended use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for individuals who require mechanical ventilation, with or without air/oxygen mixing. Trilogy 202 is suitable for children to adults weighing at least 5 kg (11 lbs). The device is intended for use in hospitals and institutions; and only for portable applications in institutional settings, such as wheelchairs and gurneys. It can be used for invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Internal tests have shown that a potentially defective component on the power management board may affect the function of some Trilogy ventilators, thereby preventing patients from receiving treatment.

Greatbatch Medical March 6, 2014 offset cup impactor-Greatbatch Medical; offset cup impactor. The standard offset cup impactor is a reusable instrument used to implant an acetabular cup during acetabular replacement surgery. The Standard Offset Cup Impactor is non-sterile and must be sterilized before being used for surgery. The standard offset cup impactor is used to implant the cup in many minimally invasive surgical methods of total hip arthroplasty (ri-IA). Since the product was first released in 2004, Greatbatch Medical has initiated global field corrective actions for the standard offset cup impactor. Greatbatch has passed the internal sterility assurance level verification test to determine that the standard deviation does not reach the sterility assurance level of 10-6. It is subject to the steam sterilization cycle and the associated impact cup

Abbott Diabetes Care; Inc. March 18, 2014 FreeStyle Flash Blood Glucose Monitor – FreeStyle Glucose Monitor System. Only for in vitro diagnosis. Store at room temperature below 86 degrees Fahrenheit (30 degrees Celsius). Use test strips only within the operating temperature range of the system listed in the user manual. Meters made in China; distributed by Abbott Diabetes Care; Alameda; CAFreeStyle mete can only be used with FreeStyle test strips and FreeStyle Control Solution. Using other brands of test strips and control solutions in combination with FreeStyle Mete may produce inaccurate results. The FreeStyle blood glucose meter has been incorporated into the OmniiPod insulin management system (manufactured by Insulet Corporation; Bedford; MA for subcutaneous insulin injection. It is designed to monitor the blood sugar of samples taken from the body. Only for IVD use; Abbott Diabetes Care has determined through internal testing and investigation, All traditional meters without voltage applied may produce out-of-range control solution results and/or false hypoglycemia results when used with a batch of Free Style test strips within the validity period.

Abbott Diabetes Care; Inc. March 18, 2014 FreeStyle Flash Blood Glucose Monitor – FreeStyle Flash Blood Glucose Monitor System.Meter Made in China; Distributed by TheraSense; Alameda; CAFreeStyle Flash Meter can only be used with FreeStyle test strips and FreeStyle Control Solution use. Using other brands of test strips and control solutions with FreeStyle Meter may produce inaccurate results. Designed to monitor the blood sugar of samples taken from the body. Only for in vitro diagnostic use; Abbott Diabetes Care has determined through internal testing and investigation that all old-style meters without voltage applied may produce out-of-range control solution results and/or errors when used with expired Free Style test strips Results of low blood sugar.

Thoratec Corporation March 21, 2014 HeartMate II System Controller – HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood by itself. It is sometimes called the heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II is attached to the heart and is designed to assist or take over the pumping function of the patient's left ventricle; the main pumping chamber of the heart. Discovered serious injuries and deaths related to the process of changing patients using the pocket system controller model from the primary system controller to the backup system controller.

Thoratec Corporation Heart Mate II pocket controller taken out of the package on March 21, 2014 – Heart Mate II pocket controller taken out of the package Product use: HeartMate II is a mechanical device that cannot be fully pumped when the heart is too weak When sending blood, it circulates its own blood throughout the body. Discovered serious injuries and deaths related to the process of changing patients using the pocket system controller model from the primary system controller to the backup system controller.

Thoratec Corporation March 21, 2014 HeartMate II LVAD pump and Pock controller kit; – HeartMate II LVAD pump and Pock controller kit; product usage: HeartMate II is a mechanical device that cannot fully pump blood by itself when the heart is too weak At times, it circulates blood throughout the body. Discovered serious injuries and deaths related to the process of changing patients using the pocket system controller model from the primary system controller to the backup system controller.

Thoratec Corporation March 21, 2014 HeartMate II implant kit with pocket controller; – HeartMate II implant kit with pocket controller; with sealing graft (NAm) and sealing graft (EU) Product use: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. Discovered serious injuries and deaths related to the process of changing patients using the pocket system controller model from the primary system controller to the backup system controller.

Dräger Medical Systems; Inc. Mar-28-2014 Infinity ACS workstations Drager PS500 power supply unit for intensive care – Infinity ACS workstations Drager PS500 power supply unit for intensive care (Evita Infinity V500) Ventilation battery capacity during short-term transfer of patients in hospitals Infinity ACS The service life of the optional PS500 power supply unit for Workstation Critical Care (Evita Infinity V500) is not as long as expected.

Recall manufacturer, release date, product name/product, reason for recall

Medical Information Technology; Inc. Mar-03-2014 MEDITECH Microbiology-MEDITECH Microbiology-Calculator/Data Processing Module; for clinical use. Possibility to remove patient results from LAB/EMR.

Toshiba American Medical Systems Corporation March 3, 2014 TSX-IOIA: Aquilion 32/64 ONE; system; X-ray; tomography; computer-TSX-101A Aquilion 32/64 ONE computer tomography X-ray system; TXS-101/ R Aquilion RXL computer tomography X-ray system; TSX-301A Aquilion One computer tomography X-ray system; TSX-301B Aquilion advanced computer tomography X-ray system; TSX-302A Aquilion Prime computer tomography X-ray system. The device is used to collect and display the cross-sectional volume of the entire body; including the head. Aquilion RXL can provide volume sets. These volume sets can be used to perform specialized research; use designated software/hardware; and be conducted by well-trained and qualified doctors. Toshiba initiated this recall because their investigation revealed that due to a problem with the X-ray output control software; the X-ray output conditions may be set incorrectly. As a result; the X-ray exposure under the scanning conditions used for the comparative study may not start.

Made by AMO Puerto Rico; Inc. Mar-03-2014 AMO TECNIS CL collapsible silicone intraocular lens with OptiEdge design-AMO TECNIS CL collapsible silicone intraocular lens with OptiEdge design; Z9002 type; Diopter size: 16.0 and 21.0. It is suitable for the first implantation of aphakic vision correction in adult patients. Some silicone TECNIS IOL may be marked with incorrect diopters.

WalkMed infusion; LLC March 3, 2014 Triton FP infusion pump – Triton FP infusion pump; part number 400000; packaged in a box. Triton volumetric infusion pump is suitable for delivering drug infusion; and providing TPN (total parenteral nutrition) and PCA (patient control analgesia). It is intended for use in hospitals; outpatient and nursing home (extended care) settings; and home care environments. WalkMed Infusion is recalling their Triton FP infusion pump; the part number is 400000 because the label on the right side of the pump contains incorrect instructions.

Change G; Incorporate AlterG anti-gravity treadmill on March 4, 2014-accessory shorts for AlterG anti-gravity treadmill. Use with AlterG anti-gravity treadmill for rehabilitation. Suppliers concentrated on using unapproved materials in the shorts, causing them to stretch more than usual, which is uncomfortable for patients.

DeRoyal Industries Inc. DeRoyal(R) ST on March 4, 2014. Circumcision forceps; reference 32-1622; size 1.3 cm-DeRoyal(R) ST. Circumcision forceps; reference 32-1622; size 1.3 cm; 1 per pack; Rx sterile EO only; issued by DeRoyal Industries; 200 De Basque Lane; Powell; TN 37849 Three batches of circumcision forceps are not manufactured It meets the specifications, so it may not be clamped to the surgical site completely and correctly.

Synthes; Inc. Mar-04-2014 Synthes 5.0mm Variable Locking Screw – Synthes 5.0mm Variable Locking Screw This device is part of a series of variable angle locking compression plates. The technology includes a variable angle combination hole on the plate shaft. The variable-angle combined hole provides the flexibility of axial compression and the variable locking capability of the entire plate shaft length. Label correction: The package insert in a 5.0mm variable locking screw package is the GP0006 (Cervical Anterior Laminar System) insert; it should be GP2848 (4.5mm VA-LCP Curved Condylar Plate System Insert).

Djo Surgical Mar-04-2014 FMP X-alt acetabular liner – FMP X-alt acetabular liner This acetabular liner is suitable for DJO Surgical hip joint system. It is used with the acetabular shell to replicate the kinematics of the natural hip joint. Packaging errors-Two different types and sizes of acetabular pads used in hip replacement surgery were incorrectly packaged in each other's outer boxes after sterilization; resulting in products being mislabeled. Externally marked as model/catalog number 931-28-248 batch/serial number 685F1034 and containing the unit with model/catalog number 932-36-252; Lot# 728F1089 is inside (1

Carestream Health Inc. March 4, 2014 Kodak 2200 intraoral X-ray system-Kodak 2200 intraoral X-ray system; catalog number 5303177; 5303169; 5303151; XR-5154323-Carestream Health; Inc. 150 Verona Street; Rochester; NY 14608 — Made in France — TROPHY 77435 Marne La Vallee — Generic/Common Name: Dental X-ray System — Category Name: Unit; X-ray; External Timer — There are four main components: X-ray tube; X-ray generation器; collimator and image receiver. These systems are permanently installed diagnostic dental X-ray systems that are used to generate X-rays for examining teeth; jaws and oral structures. Carestream received a problem report about the arm fracture caused by the apparent early failure of the Kodak 2X00 intraoral X-ray equipment arm.

Carestream Health Inc. March 4, 2014 Kodak 2100 intraoral X-ray system – Kodak 2100 intraoral X-ray system; catalog number 5303144; 8011579 — Carestream Medical; Inc. 150 Verona Street Rochester; NY 14608 — Made in France — TROPHY 77435 Marne La Vallee — Generic/Common Name: Dental X-ray System — Category Name: Unit; X-ray; External Timer — There are four main components: X-ray tube; X-ray generator; collimator and image receiver . These systems are permanently installed diagnostic dental X-ray systems that are used to generate X-rays for examining teeth; jaws and oral structures. Carestream received a problem report about the arm fracture caused by the apparent early failure of the Kodak 2X00 intraoral X-ray equipment arm.

MEDICAMAT SA Mar-04-2014 Punch Hair Matic – Punch Hair MaticA surgical hair transplantation equipment, specially designed for the automation of hair follicle transplantation. Since the marketing literature of Punch Hair Matic SAFER is mislabeled, Medicamat is starting an on-site correction.

Mako Surgical Corporation March 4, 2014 Restoris Multi-compartment Knee (MCK) System – Restoris Multi-compartment Knee (MCK) System is an implanted system designed to interact with MAKO's Robotic Arm Interactive Orthopedic System (RIO) use together. It consists of a single-compartment implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). Restoris MCK Uni is designed to carry ROM that is expected to be less than or equal to 155 degrees. In the Restoris MCK combination that is dealing with multi-compartment areas; the gap between Restoris MCK components is designed to be 3 mm to ensure that the components do not interfere with each other. It is suitable for single-compartment or multi-compartment knee replacement surgery in combination with RIO; in individuals suffering from osteoarthritis or post-traumatic arthritis of the tibia and/or patellofemoral joint surface. The product may be mislabeled and may result in the use of incorrect implants.

Heraeus Kurtz; limited liability company. March 4, 2014 Benco tartar & stain remover-BencoDental tartar and stain remover ultrasonic cleaning fluid product use: specially formulated for the removal of tartar; tartar; tobacco and food stains on dentures; bridges; orthodontic appliances; Wait. It is also used to remove permanent cement. The result of a complaint to the Heraeus Kulzer customer service department; Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451; lot #13121434 because it has an incorrect label on the direct container. Although the outer box is correctly labeled "Benco Tartar and Stain"; the direct gallon container containing the solution is incorrectly labeled "Benco Temporary C

Focus Diagnostics Inc March 5, 2014 Simplexa Flu A/B & RSV direct detection – Simplexa Flu AlB and RSV direct detection kit; intended to be used as an auxiliary means for differential diagnosis of influenza A; influenza B; and RSV virus infection in humans , Not used to detect influenza C. Model MOL2650. Due to the possibility of false positive influenza A, Focus Diagnostics began to recall certain Simplexa Flu AlB and RSV Direct test kits; influenza B and RSV signals.

KCI USA; INC. Mar-05-2014 PRE2001: Prevena incision management customizable system frame – PRE2001: Prevena incision management customizable system frame Product usage: Prevena incision management system is designed to manage the environment of surgical incisions, these incisions are sutured or sutured After closure, continue to drain through negative pressure wound therapy to maintain a closed environment and remove exudate. Prevena Incision Management System Kit/Dressing Connector-The male connector on the pipe is difficult to connect to the female connector on the Prevena tank pipe

KCI United States; INC. Mar-05-2014 PRE2055US: Prevena Customizable Dressing 5-piece Pack (US only) – PRE2055US: Prevena Customizable Dressing 5-piece Pack (US Only) Product Usage: Prevena Incision Management System is designed to manage surgery The environment maintains a closed environment and removes exudate by applying negative pressure wound therapy, and continues to drain the incision after suture or suture is closed. Prevena Incision Management System Kit/Dressing Connector-The male connector on the pipe is difficult to connect to the female connector on the Prevena tank pipe

KCI USA; INC. Mar-05-2014 PRE1055: Prevena dressing; 5-pack – PRE1055: Prevena dressing; 5 Pack Product use: Prevena incision management system is designed to maintain a closed environment and remove exudate by applying negative pressure wound therapy To manage the environment of the surgical incision that continues to drain after the suture or suture is closed. Prevena Incision Management System Kit/Dressing Connector-The male connector on the pipe is difficult to connect to the female connector on the Prevena tank pipe

KCI USA; INC. Mar-05-2014 PRE1055US: Prevena dressing; 5-pack (US only) – PRE1055US: Prevena dressing; 5-pack (US only) Product use: Prevena incision management system is designed to maintain a closed environment And through the application of negative pressure wound therapy to remove exudate to manage the environment of the surgical incision that continues to drain after the suture or suture is closed. Prevena Incision Management System Kit/Dressing Connector-The male connector on the pipe is difficult to connect to the female connector on the Prevena tank pipe

KCI USA; INC. Mar-05-2014 PRE1001US: Prevena Peeling and Placement System Kit (US only) – PRE1001US: Prevena Peeling and Placement System Kit (US only) Product Usage: Prevena Incision Management System is designed to manage the surgical environment through Maintain a closed environment and remove exudate by applying negative pressure wound therapy, and continue to drain the incision after suture or suture closure. Prevena Incision Management System Kit/Dressing Connector-The male connector on the pipe is difficult to connect to the female connector on the Prevena tank pipe

KCI United States; INC. March 5, 2014 PRE2055: Prevena Customizable Dressing 5 Piece Pack – PRE2055: Prevena Customizable Dressing 5 Piece Pack Product Usage: The Prevena Incision Management System is designed to manage the environment of surgical incisions, these incisions are being sutured or After the suture is closed, continue to drain through the negative pressure wound therapy to maintain a closed environment and remove the exudate. Prevena Incision Management System Kit/Dressing Connector-The male connector on the pipe is difficult to connect to the female connector on the Prevena tank pipe

KCI USA; INC. Mar-05-2014 PRE2001US: Prevena incision management customizable system frame (US only) – PRE2001US: Prevena incision management customizable system frame (US only) Product use: Prevena incision management system is designed to manage surgery The environment maintains a closed environment and removes exudate by applying negative pressure wound therapy, and continues to drain the incision after suture or suture is closed. Prevena Incision Management System Kit/Dressing Connector-The male connector on the pipe is difficult to connect to the female connector on the Prevena tank pipe

KCI USA; INC. March 5, 2014 PRE1001: Prevena Peeling and Placement System Kit – PRE1001: Prevena Peeling and Placement System Kit Product Usage: The Prevena Incision Management System is designed to manage the environment of surgical incisions that are closed by sutures or sutures After that, drainage is continued to maintain a closed environment and remove exudate through negative pressure wound therapy. Prevena Incision Management System Kit/Dressing Connector-The male connector on the pipe is difficult to connect to the female connector on the Prevena tank pipe

Horiba Instruments; Inc dba Horiba Medical ABX PENTRA Multical on March 5, 2014. ABX PENTRA N Control ABX PENTRA P Control – ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers that use two measurement principles: absorbance and ion selective electrodes. ABX PENTRA Multical is a freeze-dried human serum calibrator that contains chemical additives and materials of biological origin. The specified values ​​of the calibrator components are given in the attached accessories; ensure that the appropriate HORIBA ABX SAS method is optimally calibrated on the ABX PENTRA clinical chemistry analyzer. The calibrator comes in 10 vials of 3 ml. HORIBA Medical is notifying all ABX PENTRA MultiCal; Control; and P Control customers to run the creatinine rate blank method determination on ABX PENTRA 400 and PC200, and the target value of the creatinine rate blank method has been updated. This question only applies to the creatinine rate blank method value reported only on ABX PENTRA 400 and PC200 chemical analyzers. No other analyzer

Elekta; Inc. March 6, 2014 Desktop Pro TM and Desktop Pro (VMAT)-Desktop Pro TM linear accelerator control software, designed to help licensed practitioners deliver radiation to a specified target volume. During the treatment center; the gantry; and the collimator calibration procedure; incorrect values ​​or reverse values ​​may be entered.

General Electric Healthcare; LLC March 6, 2014 GSI Viewer – GE Healthcare; Model/Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer on AW VolumeShare 4 (AW 4.5) 1.10; GSI Viewer 1.10 on 5342114-3 AW VolumeShare 4 (AW 4.5); GSI Viewer 1.11 on 5342114-4 AW VolumeShare 4 (AW 4.5); GSI Viewer 1.20 on 5401757 AW VolumeShare 3 (AW4.4) . When the computed tomography X-ray system performs the secondary capture generated from the GSI Viewer; the caption information on the image is correct. However; when changing the ROI (Region of Interest) and zooming in; DICOMheader will not change to reflect the new image; therefore, the line measurement may be inaccurate.

General Electric Healthcare; LLC March 6, 2014 GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4; 5.5; or 5.6 – GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4; 5.5; or 5.6 enable automatic viewing of alarms (AVOA) function. Solar 8000i with patient data module/Transport Pro with patient data module is designed to be used under the direct supervision of licensed healthcare practitioners; or by personnel trained in the proper use of equipment by professional medical institutions; such as hospitals; clinics ; Surgery center or doctor's office. It can be used in many fields such as operating room (OR); post-anaesthesia care unit (PACU); emergency department (ED); chest pain clinic; general intensive care unit (ICU); intensive care unit; surgical intensive care unit (SICU); breathing Intensive Care Unit; Coronary Care Unit (CCU); Medical Intensive Care Unit (MICUI; Pediatric Intensive Care Unit (PICU); or Neonatal Intensive Care Unit (NICU). Patient Data Module (PDM) is designed to provide uninterrupted adults Physiological parameter data collection; non-transmission/bedside and transmission patient care events for pediatric and neonatal patients. Physiological parameter data obtained by PDM includes electrocardiogram; invasive pressure; non-invasive blood pressure; pulse oximetry; temperature; cardiac output And breathing. The device acquires, processes and stores all the above information parameters and transmits this information to the transportation or bedside central processing unit for viewing and alarm monitoring purposes. The Transport Pro patient monitor is designed to be used for internal transportation in healthcare institutions Part of the transportation monitoring system. When used with the patient data module (PDM) or TRAM acquisition module; the device is designed to provide uninterrupted physiological monitoring of adult logical parameter data; pediatrics; and neonatal patients in a transfer from a medical institution In the process of going to another area. Physiological parameter data includes electrocardiogram; invasive pressure; non-invasive blood pressure; pulse oximeter; temperature and respiration. Both PDM and TRAM acquisition modules collect; process and store all the information of the above parameters. Solar 8000i patient The monitoring system is a multi-parameter physiological patient monitoring system suitable for adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system can monitor and analyze the following parameters of all patient groups: ECG ; Invasive pressure; non-invasive blood pressure; pulse; temperature; cardiac output; respiration; pulse oximeter; venous oxygen saturation; transcutaneous pO2 and pCO2; CO2 and respiratory mechanics. Solar 8000i patient monitoring system can monitor adults and children The following parameters of the patient population: anesthetic concentration; 02; impedance electrocardiogram; EEG and bispectral index. The Solar 8000i patient monitoring system can be connected to various third-party peripheral medical devices that support serial and/or analog data output. Can be displayed Information from these devices; trends and stored in the monitoring system. Solar 8000i patient monitoring system also provides physiological data through UNITY NETWORK TM. GE Healthcare recently realized the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) function There is a potential safety issue. If the patient monitor is discharged from the CIC, the Solar 8000M/i AVOA function will stop operating the central station, and the remote automatic bedside alarm view is currently active Show on solar energy. Once this problem occurs; follow-up remote AV

Elekta; Inc. March 6, 2014 Multilead collimator – Agility.Version 3.0 Integrity interface and control software, used in the Elekta series of medical digital linear accelerators, associated with Agility collimator. During the treatment center; the gantry; and the collimator calibration procedure; incorrect values ​​or reverse values ​​may be entered.

Elekta; Inc. March 6, 2014 Multilead collimator – Agility.Version 3.1 Integrity interface and control software, used in the Elekta series of medical digital linear accelerators, associated with Agility collimator. During the treatment center; the gantry; and the collimator calibration procedure; incorrect values ​​or reverse values ​​may be entered.

Elekta; Inc. Mar-06-2014 Integrity-Integrity.Version 1.1 Integrity interface and control software for Elekta series medical digital linear accelerators. During the treatment center; the gantry; and the collimator calibration procedure; incorrect values ​​or reverse values ​​may be entered.

Hospira Inc. March 6, 2014 LifeShield Latex-Free HEMA Type Y Blood Set IV Administration Kit – *** 1) List number 126970465 Part mark: 12697-65 LifeShield Latex-Free HEMA; Type Y Blood Set; No ventilation; 88 inches with 210 micron filter pump; pre-perforated injection site and safety lock; made in Costa Rica; product inquiries should contact Hospira directly; the company; Lake Forest; IL 60045 USA; *** 2) List number 127200465 Part mark: 12720 -65 LifeShield latex-free HEMA; blood set; no ventilation; 81 inches with 170 micron filter; pump; pre-perforated injection site and safety lock; made in Costa Rica; product inquiries should contact Hospira directly; company; Lake Forest; IL 60045 United States; *** 3) Part of the list number 046419701 is marked as: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp Hospira infusion sets are used to deliver liquids; including but not limited to; blood and blood products; from the container to the patient's vascular system. Many batches of LifeShield Latex-Free HEMA Y Type Blood Set IV dosing sets were assembled incorrectly.

Elekta; Inc. Mar-06-2014 RT Desktop-RT DesktopThe EOS RT Desktop; same as the user interface of the predicate SL/SLi series; intended to be used as the user interface of the SL/SLi series linear accelerator for radiotherapy of malignant tumor diseases; Determined by a licensed doctor. During the treatment center; the gantry; and the collimator calibration procedure; incorrect values ​​or reverse values ​​may be entered.

Toshiba American Medical Systems Inc. CT system on March 6, 2014-TSX-301C Aquilion One (vision version) computed tomography X-ray system. Toshiba American Medical Systems; Inc. initiated this recall due to the failure of components used in the X-ray high-voltage generator. In some cases; X-ray exposure cannot be performed.

Mindray DS USA; Inc. dba Mindray North America Mar-07-2014 Mindray DS USA; Inc. Panorama Patient Monitoring Network – Panaroma Central Station Product usage: This device can be viewed in real time; shop; print; graph; and trend patient clinical and population Statistical data. The device can also set independent alarm limits for the data sent by the bedside monitor. Mindray has determined that there are two problems with Panorama Central Station. When Panorama CentralStation is used with Mindray V series monitors, Full Disclosure data may lag behind the Panorama system clock. In addition; when Panorama Central Station is used with Panorama Telepack, the event indicator lags behind the Panorama system clock.

Clarity Medical Systems Inc March 7, 2014 RetCam 3; RetCam Portable and RetCam Shuttle – RetCam 3; RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems; company; Pleasanton; CA 94588. General ophthalmic imaging, including retina ; Corneal and external imaging. RetCam 3 software is abnormal; RetCam Shuttle and RetCam Portable software versions are 6.0.x; 6.1.x and 6.2x, and the patient’s age is calculated incorrectly.

Shimadzu Medical Systems March 7, 2014 MUX-100; MUX-100H X-ray system-mobile X-ray system; Model: MUX-100; MUX-100H Product use: This equipment is a mobile X-ray system for Patients in hospitals who cannot move and/or emergency outpatients undergo routine X-ray photography. Shimadzu Corporation is recalling Shimadzu mobile X-ray systems (MUX-100 and MUX-100H) because the metal plate connecting the main frame and the MUX-100 column may be broken.

Leica Biosystems imaging; Inc. Mar-07-2014 ScanScope system – HER2 image analysis manual read HER2 digital slide ER/PR image analysis IHC PR breast tissue manual read digital slide ScanScope system is an automatic digital slide Create; manage; view and analyze the system. It is intended to be used for in vitro diagnostics as an aid to the pathologist in the display; detection; counting and classifying the tissues and cells of clinical interest based on specific colors; intensity; size; patterns and shapes. The IHC HER2 image analysis application is designed to help pathologists detect and semi-quantitatively measure formalin-fixed HER2/neu (c-erbB-2); paraffin-embedded normal and tumor tissues. The IHC HER2 image analysis application is intended to be used as an accessory to Dako HercepTest to help detect and semi-quantitatively measure formalin-fixed, paraffin-embedded normal and tumor Her2/neu (c-erbB-2) tissues. When used with Dako HercepTest"; it is suitable for evaluating breast cancer patients who are considering Herceptin (trastuzumab) treatment. Note: The IHC HER2 image analysis application is an auxiliary computer-assisted method that can help A qualified pathologist obtains and measures the reproducibility of images from microscope slides of breast cancer specimens stained for the presence of the HER-2 receptor protein. The accuracy of the test results depends on the quality of the immunohistochemical staining. Qualified. It is the responsibility of the pathologist of Dako to conduct appropriate morphological research and control in accordance with the instructions of Dako HercepTest to ensure the effectiveness of the IHC HER2 image analysis application to assist the HER-2/neu scoring. Dako’s actual relevance to HercepTest The clinical results have not yet been determined. Manual reading of HER2 digital slides: The ScanScope system is an automatic digital slide creation; management; viewing and analysis system. It is intended to be used for in vitro diagnostics as an aid to the pathologist in the display; detection; counting and classifying the tissues and cells of clinical interest based on specific colors; intensity; size; patterns and shapes. The IHC HER2 digital slide manual reading application is designed to help pathologists detect and semi-quantitatively measure HER-2/neu (c-erbB-2) by manually inspecting formalin digital slides. Fixed; Paraffin-embedded normal and tumor tissues were immunohistochemically stained for HER-2 receptors on a computer monitor. HER-2 results can be used to assist management; the prognosis and prediction of breast cancer treatment results. The IHC HER2 Manual Read of Digital Slides application is intended to be used as an attachment to Dako HercepTestT to help pathologists manually check HER-2/neu (c-erbB-2) formalin-fixed digital slides; paraffin pack The buried normal and tumor tissues were immunohistochemically stained for HER-2 receptors on a computer monitor. When used with Dako HercepTestT; it is suitable for evaluating breast cancer patients who are considering treatment with Herceptin (trastuzumab). Note: The actual correlation between Dako HercepTestT and Herceptin clinical results has not been determined. ER/PR image analysis: ScanScope XT system is an automatic digital slide creation; management; viewing and analysis system. It is intended to be used for in vitro diagnostics as an aid to the pathologist in the display; detection; counting and classifying the tissues and cells of clinical interest based on specific colors; intensity; size; patterns and shapes. The IHC ER image analysis application is designed to help pathologists detect and quantitatively measure normal and new ER (estrogen receptor) embedded in formalin-fixed paraffin. Aperio (now Lecia Biosystems) is providing more information to clarify the use of digital IHC breast/ER/Dako image analysis; digital IHC breast/HER2 digital reading; digital IHC breast/HER2/Dako image analysis; digital IHC breast /PR digital reading and digital IHC breast /PR/Dako image analysis and RUO products identified in the earlier notification i

Philips Healthcare; Inc. Mar-07-2014 Philips Healthcare MRx – Philips HeartStart MRx monitor/defibrillator models: M3535A; M3536A; M3536M; M3536M4; M3536M6; 861288; 861289; 861464; 861483; and 861491 MRx may be available A red X is displayed in the Ready to Use (RFU) indicator during the automatic test to notify the user that malfunction shock and pacing that may prevent delivery have been detected

Medical Linear Accelerator; Inc. Mar-07-2014 Medical Linear Accelerator-All Elekta digital accelerators, with electron and beam modulator; MLCi/MLCi2; Agile or asymmetric head product use: to deliver radiation to a defined target volume Set the default value instead of the recommended factory setting.

Carl Zeiss Meditec AG March 7, 2014 VisuMax laser keratome – The treatment kit used on the VisuMax laser keratome. Dimension M is manufactured by Carl Zeiss Meditec AG; Jena; Germany. VisuMax laser keratome is suitable for the following purposes: Making corneal flaps in patients undergoing LASIK surgery or other patients requiring laminectomy. Patients undergoing surgery or other patients who require an initial laminectomy. In the creation of lamellar corneal incision/resection for lamellar keratoplasty. Create incisions/incisions for penetrating keratoplasty and corneal harvesting. Carl Zeiss Care Pack; lot number M 130010; size M; may actually contain size S.

Megadyne Medical Products; Inc. March 7, 2014 MEGADYNE Medical Products "12FR" Inhalation Coagulator-Manually controlled 12FR Inhalation Coagulator with 10 feet cord and holster; sterile; disposable; model 0043-25; packaging Good Tyvek polyester peel-off bag; 25 sachets per box. This device is used to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissues during ENT and general surgical procedures. It is also a suction device used to remove surgical smoke and liquid from the surgical site. This device is for single use only; it cannot be cleaned or reused. Megadyne Medical Products; Inc. voluntarily recalled manually controlled 12Fr suction coagulators with 10-foot cord and 132405 holster; sterile; disposable; lot number 132405, because a small number of these suction coagulators may be connected to electrosurgery The generator is self-activated immediately after the generator, and remains active before disconnecting.

Maquet Cardiovascular US Sale; LLC March 10, 2014 MAQUET – MAQUET PLEGIOX Cardioplegia Heat Exchanger PLEGIOX Cardioplegia Heat Exchanger is used as part of the cardioplegia system for setup and maintenance during cardiopulmonary bypass The temperature within a given temperature range of a given flow rate and blood cardioplegia and crystalloid cardioplegia. This product is for single use only; the application time does not exceed 6 hours. MAQUET’s post-marketing vigilance plan found a difference that when PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in combination with a heater/cooler device, the required cardioplegia temperature may not be obtained.

Smith & Nephew Inc. March 10, 2014 RENASYS-AB Abdominal Dressing Kit with Soft Port – Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (RENASYS Soft Port Dressing Kit and Negative Pressure Wound treatment pump) Wound fluid and/or blood are not drained from under the wound dressing and the pump block alarm is not activated. The report is related to insufficient soft port sealing or improper positioning of the soft port at the wound site. Poor sealing can cause air to leak and cause inefficiencies in the fluid drain from the workplace.

Smith & Nephew Inc. March 10, 2014 RENASYS soft port dressing kit – Smith & Nephew RENASYS soft port REF: 66800799 (RENASYS soft port dressing kit used in combination with negative pressure wound therapy pump) wound fluid and/or no dressing from the wound The blood that is discharged below and the pump block alarm is not activated is related to insufficient Soft Port sealing at the wound site or improper positioning of the Soft Port opening on the wound contact dressing drape. Poor sealing can cause air to leak and cause inefficiencies in the fluid drain from the workplace.

Smith & Nephew Inc. March 10, 2014 RENASYS-F Foam Dressing Kit with Soft Port – Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794; 66800795; and 66800796 (RENASYS Soft Port The dressing kit is used in combination with a negative pressure wound therapy pump) Reports that wound fluid and/or blood are not drained from under the wound dressing and the pump blockage alarm is not activated. The soft port seal at the wound site or the soft port orifice is in contact with the dressing cloth in the wound. The position on the slip is inappropriate. Poor sealing can cause air to leak and cause inefficiencies in the fluid drain from the workplace.

Smith & Nephew Inc. Mar-10-2014 RENASYS-F XL with Soft Port – Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (Renasys Soft Port dressing kit and negative pressure wound therapy pump combined use) wound fluid and The report that blood is not drained from under the wound dressing and the pump block alarm is not activated is related to the overhang related to insufficient soft port sealing at the wound site or improper placement of the Soft Port orifice on the wound contact dressing. Poor sealing can cause air to leak and cause inefficiencies in the fluid drain from the workplace.

Smith & Nephew Inc. March 10, 2014 RENASYS-Gauze with soft port kit – Smith & Nephew RENASYS-Gauze with soft port kit REF #'s: 66800933; 66800934; 66800935; and 66800936 (RENASYS soft port dressing kit and negative Pressure wound therapy pump used in combination) Report on wound fluid and/or blood not draining from under the wound dressing and the pump blockage alarm is not activated and the soft port seal at the wound site or the position of the soft port orifice on the wound contact dressing sheet improper. Poor sealing can cause air to leak and cause inefficiencies in the fluid drain from the workplace.

Smith & Nephew Inc. March 10, 2014 RENASYS-G sterile; soft-mouthed gauze dressing kit – Smith & Nephew RENASYS-G sterile; soft-ported gauze dressing kit REF #'s: 66800961 (RENASYS soft Port dressing kit used in conjunction with negative pressure wound therapy pump) Wound fluid and/or blood are not drained from the wound dressing and report that the obstruction alarm is not activated. The soft port at the wound site is insufficiently sealed or the soft port orifice is in contact with the dressing sheet The improper location is related. Poor sealing can cause air to leak and cause inefficiencies in the fluid drain from the workplace.

Boston Scientific March 10, 2014 Boston Scientific RunWay" guide catheter-Boston Scientific; RunWay" guide catheter; UPN H749389696640; catalog number 38969-664. Boston Scientific is initiating a recall of a batch of (2013040058) RunWay guide catheters. Boston Scientific has realized that the sterile bags of this batch of equipment may not be completely sealed, and the sterility may be affected. To date; Boston Scientific has received complaints about this issue. Unsealed pou The most common adverse health consequences expected

General Electric Healthcare; LLC March 10, 2014 X-ray systems – GE Healthcare; Innova 2100IQ; Innova 3100; Innova 3100IQ; Innovative 4100; Innova 4100IQ Innova 2121IQ; Innova 3131IQ; Cardiovascular X-ray imaging system (X-ray generator Rotor V3 and Heater V4 boards are installed). Digital fluoroscopy imaging system is used to generate fluoroscopy images of human anatomy for diagnosis and interventional angiography procedures. It is intended to replace the perspective image obtained through image enhancement technology. This device is not suitable for mammography applications. The Innova 3100 system is suitable for generating fluoroscopic images of human anatomy for angiography; and optional; rotation and angiography procedures. It is intended to replace the perspective image obtained through image enhancement technology. The digital fluoroscopy imaging system is suitable for diagnosis of human anatomy and interventional angiography procedures. It is designed to replace the image intensifier fluoroscopy system in all diagnostic or interventional procedures. This device is not suitable for mammography applications. The new tilt table will support the implementation of procedures such as carbon dioxide studies; venography. Digital fluoroscopy imaging system with bolus tracking option is used to generate fluoroscopy images of human anatomy for diagnosis and intervention; option Bolus can perform lower extremity subtraction angiography. This device is not suitable for mammography applications. The Innova 2100-IQ system is suitable for generating fluoroscopic images of human anatomy for angiographic diagnosis and interventional surgery; and optional; rotating angiography procedures. It is also suitable for generating fluoroscopic images of human anatomy for heart disease diagnosis and interventional surgery. It is intended to replace the perspective image obtained through image enhancement technology. This device is not suitable for mammography applications. For Innova 4100; Innova 4100IQ; Innovation 3100; Innova 3100 IQ; Innova 2100IQ with Innova 3T option: Innova system is suitable for generating fluoroscopic images of human anatomy for angiography; diagnostic and intervention procedures; and optional; rotating imaging procedures . They are also used for fluoroscopy images of adult body anatomy for cardiologists; diagnosis; and interventional procedures. They are intended to replace perspective images obtained through image enhancement technology. These devices are not suitable for mammography applications. Innova CT is a software option; 3D volume is reconstructed from the rotational fluoroscopy acquisition to provide images that help the doctor's diagnosis; surgical planning; interventional surgery and treatment follow-up. Innova CT is used to image bones and soft tissues and other internal body structures. Innova CT is not suitable for mammography applications. For Innova 4100; Innova 4100IQ; Innovation 3100; Innova 3100 IQ; Innova 2100IQ with Innova 3D or InnovaSpin options: Innova system is suitable for generating fluoroscopic images of human anatomy for angiography; diagnostic and interventional procedures; and optional; Rotate the imaging program. They are also used for fluoroscopy images of adult body anatomy for cardiologists; diagnosis; and interventional procedures. They are intended to replace perspective images obtained through image enhancement technology. These devices are not suitable for mammography applications. Innova 3D is a software option that can reconstruct 3D volumes from rotating fluoroscopy acquisitions to help doctors in diagnosis; surgical planning; interventional surgery and treatment follow-up. It is not suitable for mammography applications. InnovaSpin is a software option that allows fast rotating spin angiography. It is not suitable for mammography applications. : GE Healthcare is aware of potential safety issues involving the innova system. The Innova system may unexpectedly stop transmitting X-rays after the power-on or reset cycle, which may result in the loss of real-time interventional imaging. There are no reports of injuries due to this problem.

Steris Corporation Validated SixCess 270FP Challenge Pack on March 10, 2014 – Validated SixCess 270FP Challenge Pack; STERIS Corporation; 5960 Heisley Road; Mentor; Oh 44060; 440-354-2600. The VERIFY SixCess 270FP Challenge Pack is used to monitor the steam sterilization load of the steam sterilization cycle using a typical medical dynamic air removal process at 270F. STERIS has determined that the external shipping packaging of a batch of the VERIFY SixCess Challenge Pack (batch number #024552A) incorrectly identified the batch as batch number #024522A.

Synthesis; Inc. Mar-11-2014 Synthes Small Notch Titanium Reconstructive Plate – Synthes Small Notch Titanium Reconstructive Plate Product Usage: Synthes Small Notch Titanium Reconstructive Plate set provides fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. A variety of implants can be adapted to different anatomical structures; precision-made instruments help implant implants. The lateral inclination of the implant plate of the hole allows the screw to be angled. The elongated center hole provides flexibility for screw placement. A variety of length options can meet the requirements of individual situations. Some modules containing Synthes Small Notch Titanium Reconstructive Plate set are distributed by Spine sales consultants, although it is not suitable for certain spine applications.

Biosense Webster; Inc. March 11, 2014 PENTARAY NAV Catheter – PENTARAY NAV High Density Mapping Catheter; Item No. D128201; D128202; D128204; D128205. Biosense Webster PENTARAY NAV High Density Mapping Catheter is suitable for multiple heart structures in the heart Electrode electrophysiological mapping; IE; recording or stimulation only. The catheter is designed to obtain electrograms of the atria and ventricular regions of the heart. Biosense Webster is recalling PentaRay navigation catheters because it has the potential to separate part of the tip from the catheter shaft.

General Electric Healthcare; LLC GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850 on March 11, 2014. – GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 CARESCAPE Monitor B650 is a multi-parameter patient monitor designed to be used in multiple areas and hospital transportation in professional medical institutions. CARESCAPE Monitor B650 is suitable for adults; pediatrics; and neonatal patients, one patient at a time. CARESCAPE Monitor B650 is used for monitoring and recording; and generating alarms; hemodynamics (including ECG; ST segment; arrhythmia detection; ECG diagnostic analysis and measurement; invasive pressure; non-invasive blood pressure; pulse oxygen saturation; cardiac output ; Temperature and mixed venous oxygen saturation); impedance breathing; airway gases (CO2; O2; N2O and anesthetics); spirometry; gas exchange; and neurophysiology (including EEG; entropy; bispectral index (BIS) ) And neuromuscular transmission (NMT) status. CARESCAPE Monitor B650 can be a stand-alone monitor or connected to other equipment. It can also be connected to other monitors for remote viewing and data management software equipment. CARESCAPE Monitor B650 is designed to Use under the direct supervision of licensed healthcare practitioners; or by trained personnel to use the equipment correctly in professional medical institutions. CARESCAPE Monitor B650 is not designed for K092027 CARESCAPE Monitor B850 CARESCAPE Monitor B850 is a multi-parameter high-sensitivity patient monitor It is suitable for multiple areas in professional medical institutions. CARESCAPE Monitor B850 is suitable for adult, pediatric and neonatal patients. CARESCAPE Monitor B850 system is used to monitor hemodynamics (including ECG; ST segment; arrhythmia detection; ECG diagnostic analysis And measurement; invasive pressure; non-invasive blood pressure; pulse oximeter; cardiac output; temperature; impedance respiration and SvO2 (mixed venous oxygen saturation); airway gas (Fi/Et CO2; 02; N20 and anesthetics); vital capacity Measurement method; gas exchange (02 consumption (VO2); carbon dioxide production (VCO2); energy expenditure (BE); and respiratory quotient (RQ)) and neurophysiology (including electroencephalogram (EEG); entropy; bispectral index (BIS) ) And neuromuscular transmission (NMT)) monitoring) status. CARESCAPE Monitor B850 provides alarms; trends; snapshots and events; and calculations, which can be connected to monitors; printers and recording devices. CARESCAPE Monitor B850 can be an independent monitor or Connect to other equipment. It can also be connected to other monitors via the network for bed-to-bed viewing and data management software equipment. CARESCAPE Monitor B850 is designed to be used under the direct supervision of a licensed healthcare practitioner; or by a professional Medical institutions use equipment-trained personnel correctly. Except for healthcare practitioners; CARESCAPE Monitor B850 is designed to provide qualified service personnel with configuration and troubleshooting functions. CARESCAPE Monito r B850 is not suitable for use during MRI. K131414 CARESCAPE Monitor B850 CARESCAPE Monitor B850 is a multi-parameter high-sensitivity patient monitor, suitable for multiple areas in professional medical institutions. CARESCAPE Monitor B850 is suitable for adults; pediatrics; and neonatal patients, one patient at a time. CARESCAPE Monitor B850 system is suitable for monitoring hemodynamics (including ECG; ST segment; arrhythmia detection; ECG diagnostic analysis and measurement; invasive pressure; non-invasive blood pressure; pulse oximetry; cardiac output; thermal dilution and pulse contour) ; Temperature; mixed venous oxygen saturation; and central venous oxygen saturation). Respiration [impedance breathing; airway gases (CO2; 02; N20 and anesthetics); spirometry; Gas Exchange] and NGE Healthcare have recently realized the potential safety issues associated with CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These problems include NIBP (non-invasive blood pressure) and bed-to-bed problems.

Horiba Instruments; Inc dba Horiba Medical March 11, 2014 ABX PENTRA ML-Equipment Name: ABX PENTRA ML Model/Part Number: A11A01652Lot/Serial Number: Not Applicable Software Version: All versions are subject to this correction. Product use: ABX PENTRA ML is a software data management system designed to be used in ABX blood analyzers. HORIBA Medical initiated the recall of all software versions of ABX PENTRA ML (model A11A06152) because of software errors that may transmit incorrect results to the laboratory information system.

Accumetrics Inc March 11, 2014 VerifyNow IIb/IIIa test-VerifyNow IIb/IIIa test; article number 85310; 10-test kit and article number 85011; 25-test kit. Product use: The VerifyNow system is a turbidity-based optical detection system that can measure platelet-induced aggregation. The system consists of an instrument; disposable testing equipment and quality control materials. The VerifyNow IIb/IIIa test is semi-quantitative; the whole blood platelet function test is used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. The VerifyNow Ilb/Illa test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. Accumetrics is recalling the VerifyNow IIb/IIIa test because it may cause false low platelet aggregation unit (PAU) results to be reported. Incorrect low PAU results may result in low percent inhibition calculations or low baseline PAU.

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Withdrawal Syringe – G2001: 3ml line draw; Luer sliding syringe (heparin concentration: 23.5 IU/mL) with Filter-Pro device; Needle-Pro The equipment and 23G x 1 needle arterial blood sampling line extraction syringe are sterile; disposable equipment; in vitro diagnostic equipment for drawing arterial blood through the arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Withdrawal Syringe – 4043W-2: 3ml line draw; Luer sliding syringe (heparin concentration: 23.5 IU/mL) with Filter-Pro device; syringe The tip cap and 6 mL Luer sliding syringe arterial blood sampling line extraction syringe are sterile; disposable equipment; in vitro diagnostic equipment used to draw arterial blood through the arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Withdrawal Syringe – G1762: 3ml line draw; Luer lock syringe (heparin concentration: 23.5 IU/mL) with Filter-Pro device; syringe tip cap ; And 5 mL Luer lock syringe arterial blood sampling line extraction syringe is sterile; disposable equipment; in vitro diagnostic equipment used to draw arterial blood through the arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Extraction Syringe – G1725: 3ml line extraction; Luer sliding syringe with Filter-Pro device (heparin concentration: 23.5 IU/mL) and with Filter -Pro device's 1 mL Line Draw Luer sliding syringe (heparin concentration: 23.5 IU/mL) The arterial blood sampling line drawing syringe is sterile; disposable equipment; in vitro diagnostic equipment for drawing arterial blood through the arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Withdrawal Syringe – 4040-2: Umbilical cord 3ml line draw; Luer Lock Syringe (heparin concentration: 23.5 IU/mL) with Filter-Pro device; 22g x 1 needle; and Point-Lok needle safety device Arterial blood sampling line extraction syringe is sterile; disposable equipment; in vitro diagnostic equipment used to draw arterial blood through the arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Withdrawal Syringe – G1777: Umbilical cord (2) 3ml line extraction; Luer lock syringe with Filter-Pro device (heparin concentration: 23.5 IU/mL) And (2) The Needle-Pro device with 22G x 1needlesArterial Blood Sampling Line Draw syringe is sterile; a disposable device; an in vitro diagnostic device for drawing arterial blood through an arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Withdrawing Syringe – 4043G-2: 3ml line draw; Luer sliding syringe (heparin concentration: 23.5 IU/mL) with Filter-Pro device and ice pack artery The blood sampling line extraction syringe is sterile; disposable equipment; in vitro diagnostic equipment used to draw arterial blood through the arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Extraction Syringe – 4042LH: 3ml line extraction; Luer Lock Syringe (heparin concentration: 7 IU per ml) with Filter-Pro device Arterial Blood Sampling Line Extraction Syringe It is sterile; disposable equipment; in vitro diagnostic equipment used to draw arterial blood through the arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Drawing Syringe – 4043E: 3ml line drawing; Luer sliding syringe (heparin concentration: 23.5 IU per milliliter) with Filter-Pro device (sold in Europe only) The arterial blood sampling line drawing syringe is sterile; a disposable device; an in vitro diagnostic device for drawing arterial blood through an arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Drawing Syringe – 4042-2: 3 ml line drawing; Luer Lock Syringe (heparin concentration: 23.5 IU per ml) with Filter-Pro device for arterial blood sampling The line drawing syringe is sterile; a disposable device; an in vitro diagnostic device for drawing arterial blood through an arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Withdrawal Syringe – 4042E: 3ml line draw; Luer Lock Syringe (heparin concentration: 23.5 IU per ml) with Filter-Pro device (only sold in Europe) The arterial blood sampling line drawing syringe is sterile; a disposable device; an in vitro diagnostic device for drawing arterial blood through an arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Extraction Syringe – G1469J: 3 ml line extraction; Luer sliding syringe (heparin concentration: 23.5 IU per ml) with Filter-Pro device (only sold in Japan) The arterial blood sampling line drawing syringe is sterile; a disposable device; an in vitro diagnostic device for drawing arterial blood through an arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Smith Medical ASD; Inc. March 12, 2014 Portex Arterial Blood Sampling Line Drawing Syringe – 4043-2: 3ml line drawing; Luer sliding syringe with Filter-Pro device (heparin concentration: 23.5 IU/mL) Arterial blood The sampling line extraction syringe is sterile; disposable equipment; in vitro diagnostic equipment used to draw arterial blood through the arterial line. This product is not for injection. Portex arterial blood sampling line drawing syringe plunger tip problem

Lin-Zhi International Inc Mar-12-2014 Urinalysis Drugs of Abuse (DAU) cTHC (cannabinoid) control level 2 (62.5 ng/ml)-Cannabinoid DAU calibrator control level 1 (62.5 ng/mL) sterile urine Liquid should be treated as potentially infectious. IVD; Cannabinoid (cTHC also known as THC version c) DAU negative and positive controls are fluids based on human urine and are readily available. The composition is a processed drug-free human urine matrix; contains buffers; stabilizers; and less than 0.09% sodium azide. A control was prepared by adding a known concentration of 11-nor-9-THC-9-COOH to the drug-free matrix. cTHC is the abbreviation of 11-nor-9-THC-9-COOH, and may be abbreviated as THC in the body of this report. The reference substance contains 37.5 ng/mL and 62.5 ng/mL cTHC; 10% is analyzed by GC/MS or LC/MS. Linzhi International inc. Sunnyvale; CA 94085 cannabinoid drugs of abuse (DAU) negative and positive controls are used as test quality control materials to monitor the precision of Linzhi International; Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) is used in many automated Performed on a clinical chemistry analyzer. Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 The batches mentioned may have the concentration reading at the end of the shelf life due to the use of obsolete but not expired secondary inventory to produce the product. reduce.

Lin-Zhi International Inc March 12, 2014 Drugs of Abuse Urinalysis (DAU) cTHC (cannabinoid) control level 1 (37.5ng/ml)-Cannabinoid DAU calibrator control level 1 (37.5 ng/mL) sterile Urine should be treated as potentially infectious. IVD; Cannabinoid (cTHC also known as THC version c) DAU negative and positive controls are fluids based on human urine and are readily available. The composition is a processed drug-free human urine matrix; contains buffers; stabilizers; and less than 0.09% sodium azide. A control was prepared by adding a known concentration of 11-nor-9-THC-9-COOH to the drug-free matrix. cTHC is the abbreviation of 11-nor-9-THC-9-COOH, and may be abbreviated as THC in the body of this report. The reference substance contains 37.5 ng/mL and 62.5 ng/mL cTHC; 10% is analyzed by GC/MS or LC/MS. Linzhi International inc. Sunnyvale; CA 94085 cannabinoid drugs of abuse (DAU) negative and positive controls are used as test quality control materials to monitor the precision of Linzhi International; Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) is used in many automated Performed on a clinical chemistry analyzer. Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 The batches mentioned may have the concentration reading at the end of the shelf life due to the use of obsolete but not expired secondary inventory to produce the product. reduce.

BioMerieux Inc March 12, 2014 bioMerieux PREVI Isola system – bioMerieux PREVI Isola system (general; microbiology; diagnostic medical equipment); (REF 29500/29500R); bioMerieux; hazel; Mo. The company has determined that the product may not be able to dispense the sample on the agar plate, resulting in "undispensable" along with the urine sample. This may lead to "false" negative growth results.

Philips Medical Systems; Inc. March 12, 2014 Phillips HeartStart MRx monitor/defibrillator – Philips HeartStart MRx monitor/defibrillator models: M3535A and M3536A with Q-CPR meter option B08 HeartStart MRx for terminating ventricular Tachycardia and ventricular fibrillation. This equipment is for use by qualified medical personnel who have been trained in equipment operation and have passed basic life support training; advanced cardiac support; or defibrillation. When using the HeartStart MRx. with the Q-CPR meter in defibrillation mode, it must be used by a doctor or follow the doctor's instructions; the Q-CPR meter may incorrectly display the "Do not touch the patient" icon.

Biomet 3i; LLC Mar-12-2014 Contra-Angle Torque Driver Kit – Contra-Angle Torque Driver Kit Product Usage: Molded plastic trays are used to hold various dental instruments for autoclaving. In the recently revised sterilization verification test; the accompanying surgical tray does not meet the required sterility assurance level.

Biomet 3i; LLC March 12, 2014 Navigator Surgical Kit – Navigator Surgical Kit Product Usage: Molded plastic trays are used to hold various dental instruments for autoclaving. In the recently revised sterilization verification test; the accompanying surgical tray does not meet the required sterility assurance level.

Biomet 3i; LLC March 12, 2014 Contra-Angle Torque Driver Kit-Used for certain and external connections. Product Usage: Molded plastic trays are used to hold various dental instruments for autoclaving. In the recently revised sterilization verification test; the accompanying surgical tray does not meet the required sterility assurance level.

Biomet 3i; LLC March 12, 2014 Contra-Angle Torque Driver Kit-A contra-angle torque driver kit for certain internal connections. Product use: Molded plastic trays are used to hold various dental instruments for autoclaving. In the recently revised sterilization verification test; the accompanying surgical tray does not meet the required sterility assurance level.

Biomet 3i; LLC March 12, 2014 Tapered Navigator Some surgical kits – Tapered Navigator Some surgical kit product uses: Molded plastic trays are used to hold various dental instruments for autoclaving. In the recently revised sterilization verification test; the accompanying surgical tray does not meet the required sterility assurance level.

DePuy Orthopedics; Inc. Mar-13-2014 S-ROM Noiles Rotating Hinge Femur with Pin – REF 623411 R S-ROM Noiles Rotating Hinge; Femoral Rotating Hinge Glue (with pin); Right; Small; Sterile RQty 1 S- The ROM hinged knee joint femoral component is used in revision surgery where there is significant bone loss or ligament instability and additional support is required. The S-Rom femur and insert are brought into almost every revision case as a backup when the MCL is damaged during surgery. If additional restraint is required, the surgeon can use the S-ROM femur and insert. S-ROM femur is used in less than 10% of knee revision surgery; but it is almost always present. DePuy Orthopedics has determined the possibility of forming holes in the inner and outer flexible bags that form a sterile barrier for the S-ROM Noiles Rotating Hinge Femur with Pin device. The outer carton and shrink packaging are intact. The software package is being redesigned to solve this problem. The S-ROM Noiles Rotating Hinge Femur with Pin device will remain in the inventory of the US distributor during the pa

DePuy Orthopedics; Inc. Mar-13-2014 S-ROM Noiles Rotating Hinge Femur with Pin – REF 623421 L S-ROM Noiles Rotating Hinge; Femoral rotating hinge cementing (with pin); left; X-small; sterile RQty 1 The S-ROM hinged knee joint femoral component is used in revision surgery where there is significant bone loss or ligament instability and additional support is required. The S-Rom femur and insert are brought into almost every revision case as a backup when the MCL is damaged during surgery. If additional restraint is required, the surgeon can use the S-ROM femur and insert. S-ROM femur is used in less than 10% of knee revision surgery; but it is almost always present. DePuy Orthopedics has determined the possibility of forming holes in the inner and outer flexible bags that form a sterile barrier for the S-ROM Noiles Rotating Hinge Femur with Pin device. The outer carton and shrink packaging are intact. The software package is being redesigned to solve this problem. The S-ROM Noiles Rotating Hinge Femur with Pin device will remain in the inventory of the US distributor during the pa

DePuy Orthopedics; Inc. Mar-13-2014 S-ROM Noiles Rotating Hinge Femur with Pin – REF 623421 RS-ROM Noiles Rotating Hinge; Femoral rotating hinge cementing (with pin); Yes; X-small; sterile RQty 1 S- The ROM hinged knee joint femoral component is used in revision surgery where there is significant bone loss or ligament instability and additional support is required. The S-Rom femur and insert are brought into almost every revision case as a backup when the MCL is damaged during surgery. If additional restraint is required, the surgeon can use the S-ROM femur and insert. S-ROM femur is used in less than 10% of knee revision surgery; but it is almost always present. DePuy Orthopedics has determined the possibility of forming holes in the inner and outer flexible bags that form a sterile barrier for the S-ROM Noiles Rotating Hinge Femur with Pin device. The outer carton and shrink packaging are intact. The software package is being redesigned to solve this problem. The S-ROM Noiles Rotating Hinge Femur with Pin device will remain in the inventory of the US distributor during the pa

Grus Medical; Inc March 13, 2014 Gyrus ACMI Disposable Falope-Ring with Applicator Kit – Gyrus ACMI Disposable Falope-Ring with Applicator Kit. REF 006889-901 and REF 005280-901 (with 8 mm disposable Trocan). Sterile EO. Only for one-time use. The disposable Falope-Ring Band applicator is sterile; two bands; double incision instruments. The dual-strap applicator allows the doctor to occlude both fallopian tubes without removing the applicator from the abdominal cavity. Falope-Ring Band and applicator kit are suitable for female sterilization (permanent contraception). Due to the abnormal packaging process of a certain batch of disposable Falope-Ring Band Kit; there may be a defective seal, which may break the sterile barrier of the package and may endanger the sterility of the product. It may or may not be easy to see violations.

DePuy Orthopedics; Inc. Mar-13-2014 S-ROM Noiles Rotating Hinge Femur with Pin – REF 623401 LS-ROM Noiles Rotating Hinge; Femoral Rotating Hinge Glue (with pin); Left; Medium; Sterile RQty 1 S- The ROM hinged knee joint femoral component is used in revision surgery where there is significant bone loss or ligament instability and additional support is required. The S-Rom femur and insert are brought into almost every revision case as a backup when the MCL is damaged during surgery. If additional restraint is required, the surgeon can use the S-ROM femur and insert. S-ROM femur is used in less than 10% of knee revision surgery; but it is almost always present. DePuy Orthopedics has determined the possibility of forming holes in the inner and outer flexible bags that form a sterile barrier for the S-ROM Noiles Rotating Hinge Femur with Pin device. The outer carton and shrink packaging are intact. The software package is being redesigned to solve this problem. The S-ROM Noiles Rotating Hinge Femur with Pin device will remain in the U.S. dealer's inventory

DePuy Orthopedics; Inc. Mar-13-2014 S-ROM Noiles Rotating Hinge Femur with Pin – REF 623411 L; S-ROM Noiles Rotating Hinge; Femoral Rotating Hinge Glue (with pin); Left; small; sterile RQty 1 The S-ROM hinged knee joint femoral component is used in revision surgery where there is significant bone loss or ligament instability and additional support is required. The S-Rom femur and insert are brought into almost every revision case as a backup when the MCL is damaged during surgery. If additional restraint is required, the surgeon can use the S-ROM femur and insert. S-ROM femur is used in less than 10% of knee revision surgery; but it is almost always present. DePuy Orthopedics has determined the possibility of forming holes in the inner and outer flexible bags that form a sterile barrier for the S-ROM Noiles Rotating Hinge Femur with Pin device. The outer carton and shrink packaging are intact. The software package is being redesigned to solve this problem. The S-ROM Noiles Rotating Hinge Femur with Pin device will remain in the U.S. distributor's inventory during the sale period

DePuy Orthopedics; Inc. Mar-13-2014 S-ROM Noiles Rotating Hinge Femur with Pin – REF 623401 R; S-ROM Noiles Rotating Hinge; Femur Rotating Hinge Glue (with pin); Right; Medium; Sterile RQty 1 S -ROM hinged knee joint femoral component is used in revision surgery where there is significant bone loss or ligament instability and additional support is required. The S-Rom femur and insert are brought into almost every revision case as a backup when the MCL is damaged during surgery. If additional restraint is required, the surgeon can use the S-ROM femur and insert. S-ROM femur is used in less than 10% of knee revision surgery; but it is almost always present. DePuy Orthopedics has determined the possibility of forming holes in the inner and outer flexible bags that form a sterile barrier for the S-ROM Noiles Rotating Hinge Femur with Pin device. The outer carton and shrink packaging are intact. The software package is being redesigned to solve this problem. The S-ROM Noiles Rotating Hinge Femur with Pin device will remain in the U.S. distributor's inventory during the sale period

Elekta; Inc. March 13, 2014 XiO RPT system – XiO RPT system The XiO RTP system is used to develop a treatment plan for any cancer patient who has received external beam radiation therapy or brachytherapy. The system will calculate and display; on the screen and in hard copy; for a given treatment, the two-dimensional or three-dimensional radiation dose distribution in the patient's body. When Elekta electric wedges are used with dynamic conformal arcs, the dose and monitoring unit values ​​cannot be calculated correctly.

Veritas; LLC Janssen Diagnostics March 13, 2014; LLC-CELLTRACKS ANALYZER II (product code 9555) Product use: CELLTRACKS ANALYZER II is a semi-automatic fluorescence microscope; composed of analyzers; dedicated computer with CELLTRACKS software; Monitor; keyboard; mouse and uninterruptible power supply (UPS). The system also supports an optional remote review workstation (RRW); it consists of a dedicated computer with CELLTRACKS software; monitor; keyboard and mouse. The use of this product requires training and should be used under the supervision of laboratory management personnel. CELLTRACKS ANALYZER II is used to analyze rare cells isolated from biological fluids (including whole blood). It is used in conjunction with the CELLTRACKS AUTOPREP system; it uses specific kits to automate and standardize sample preparation. An optional remote viewing workstation is also provided to provide remote viewing of images and reporting results. Janssen diagnosis; LLC received a complaint about a malfunction of the CELLTRACKS ANALYZER II camera.

Mar Cor purification Mar-13-2014 Mar Cor purification reverse osmosis system – Mar Cor purification CWP reverse osmosis system. Models 101; 102; 104; and 106. There is a potential for the crimp connection at the pump head assembly. The wiring of the reverse osmosis pump head may generate resistance, which may cause resistance heating of surrounding components. If this happens; the pump head assembly may experience melting of plastic parts and may generate smoke/fire and cause equipment downtime.

General Electric Healthcare; LLC March 13, 2014 VG Hawkeye – GE Healthcare Varicam/VG and VG Hawkeye equipment Product use: The intended use of the Quasar system is to perform general nuclear medicine imaging procedures to detect the uptake of radioisotope tracers in patients ; Various scanning modes supported by various acquisition types and optional imaging functions are used to improve image quality in oncology; cardiology; neurology and other clinical diagnostic imaging applications. Scanning modes include planar (static; multi-door; dynamic; whole-body scan) and tomography (SPECT; gated SPECT; whole-body SPECT; camera-based PET). Acquisition types include single and multi-isotopic/multi-peak frame/list mode single-photon and positron imaging. Optional imaging enhancement features include various collimators; gating through physiological signals; real-time automatic body shaping; and CT-based attenuation correction and functional anatomical mapping. Potential safety issues related to accidental radial probe movement; this may occur during patient setup or at the end of patient scan. This failure mode has been observed on a single system; where the detector moves to the initial position and then slowly begins to drift inward toward the patient. This generates visual and audio alarm conditions on the console and rack. N

General Electric Healthcare; LLC March 13, 2014 Helix – Elscint APEX Helix; double head; multi-purpose; slip ring; digital gamma camera Product use: The intended use of the Quasar system is to perform general nuclear medicine imaging procedures to examine the patient's body Uptake of radioisotope tracers; use of various acquisition types and various scanning modes supported by optional imaging functions to improve image quality in oncology; cardiology; neurology and other clinical diagnostic imaging applications. Scanning modes include planar (static; multi-door; dynamic; whole-body scan) and tomography (SPECT; gated SPECT; whole-body SPECT; camera-based PET). Acquisition types include single and multi-isotopic/multi-peak frame/list mode single-photon and positron imaging. Optional imaging enhancement features include various collimators; gating through physiological signals; real-time automatic body shaping; and CT-based attenuation correction and functional anatomical mapping. Potential safety issues related to accidental radial probe movement; this may occur during patient setup or at the end of patient scan. This failure mode has been observed on a single system; where the detector moves to the initial position and then slowly begins to drift inward toward the patient. This generates visual and audio alarm conditions on the console and rack. N

General Electric Healthcare; LLC March 13, 2014 Infinia – GE Healthcare Infinia and Infinia Hawkeye nuclear medicine systems. Suitable for dual-head variable-angle gamma cameras; Hawkeye option of dual-head variable-angle gamma cameras (including GE Quasar nuclear medicine system). Nuclear medicine system Infinia equipment product use: The intended use of the Quasar system is to perform general nuclear medicine imaging procedures to detect the absorption of radioisotope tracers in patients; use various scanning modes supported by various acquisition types and aim to improve oncology Optional imaging functions for image quality; cardiology; neurology and other clinical diagnostic imaging applications. Potential safety issues related to accidental radial probe movement; this may occur during patient setup or at the end of patient scan. This failure mode has been observed on a single system; where the detector moves to the initial position and then slowly begins to drift inward toward the patient. This generates visual and audio alarm conditions on the console and rack. N

Atricure Inc March 14, 2014 AtriCure Reusable Clip Applier-A reusable clip applier manufactured by AtriCure; Company; 6217 Central Park Avenue; Westchester; OH 45069. The Reusable Clip Applier (Applier ) Is intended to be used to deploy Gilinov-Cosgrove LAA Clip (Clip). Gillinov-Cosgrove left atrial appendage clip (clip) is an implantable device used to seal the left atrial appendage. The customer notified the company that the handle spring of the RCD1 device was broken.

Mar Cor purification Mar-14-2014 Mar Cor purification Millenium HX portable reverse osmosis system. – Mar Cor purifies Millenium HX portable reverse osmosis system. Model number 3025975. Product use: The water purification system is designed to be used as a dialysis accessory to produce water through reverse osmosis for hemodialysis equipment. High inlet water pressures that exceed specifications and solenoid valves that do not meet the application may cause delays in treatment.

DeRoyal Industries Inc. March 14, 2014 DeRoyal(R) limb support; cotton adjustable; universal; REF M2017; – DeRoyal(R) limb support; cotton adjustable; universal; REF M2017 product use: suitable for limb fixation Mild to moderately agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others, the product musty smell

Elekta; Inc. Mar-14-2014 Medical linear accelerator-SL & SLi series (Mod 15/18/20/25) linear accelerator is used for radiation therapy of malignant tumor diseases. The customer is resetting to default values ​​other than the recommended factory settings.

China Daheng Group Co., Ltd. March 14, 2014 Denlase: Diode Laser Treatment System and Penlase Dental Laser Treatment System – Denlase: Diode Laser Treatment System and Penlase: Dental Laser Treatment System Surgical Power. Surgical powered laser instrument. Failure to provide the purchaser with a calibration procedure; as required by 21 CFR 1040.11(a)(2). For example; the user manual does not contain calibration procedures for Denlase or Penlase lasers

Biomet 3i; LLC March 17, 2014 BellaTek zirconia dental abutment – ​​Partial marking of dental abutment: "4555 Riverside Drive Palm Beach Gardens; FL 33410 USA 1-800-342-5454***EDAZ; EDAZx and ILDExxx* **BellaTek zirconia abutment position number: XX abutment; Pilier; abutment; abutment; Pilastro; Pilar*** Rx only ***non-sterile; disinfect before use.***Biomet 3i Dental Iberica SL* **Biomet 3i Dental Abutments are suitable for use as an attachment for intraosseous dental implants to support restorations for edentulous or partially edentulous patients. These are designed to support single and multiple dental restorations. Received and Reports on BellaTek zirconia dental abutment fractures from Biomet 3i.

Alere San Diego; Inc. Mar-17-2014 Drugs of Abuse Screen-Product brand name: Alere Triage TOX MTD Drug Screen; catalog number 94400; batches of W56013B and W56035B.25 are separately packed in a labeled kit. Indications for use: Alere Triage TOX Drug Screen is a fluorescent immunoassay used with Alere Triage Meters to qualitatively determine the presence of drugs and/or major metabolites above the threshold concentration of up to 10 different drug classes; including Acetaminophen/paracetamol detection; amphetamine; methamphetamine; barbiturates; benzodiazepines; cocaine; methadone; opiates; phencyclidine; THC and tricyclic antibodies in urine Depressive medicine. When the acetaminophen/paracetamol is taken at or above the therapeutic dose, the acetaminophen/paracetamol test will produce a positive result. This test only provides preliminary results. The results of any drug abuse test must be subject to clinical considerations and professional judgment; especially when evaluating preliminary positive results. In order to obtain confirmed analysis results; a more specific alternative chemical method is needed. Gas chromatography/mass spectrometry (GC/MS); liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) and high performance liquid chromatography (HPLC) are common confirmation methods. Quantitative serum acetaminophen/paracetamol measurement is a common method of confirming preliminary positive acetaminophen/paracetamol results. Alere San Diego; Inc. is initiating a recall of Alere Triage TOX Drug Screen; catalog number 94400; batches W56013B and W56035B, because Alere's investigation showed that these batches of PCP (phencyclidine) have a higher frequency of false negative results The frequency shown in the package insert. If you have questions about the previously reported results.

Precision Technology; Inc. Mar-18-2014 Gibrat Multiaxial Screws – Gibrat Spine System Multiaxial Screws are designed to promote cervical fusion; and thoracic spine; (C3-T3); Gibraltar Spine System is suitable for the following situations: DDD (disc-derived cervical Pain with intervertebral disc degeneration, confirmed by history and radiological studies); spondylolisthesis; spinal stenosis; rupture; misalignment; previous failure of fusion and/or tumor. After cervical/upper thoracic (C3-T3) spinal fracture/dislocation or trauma reduction, the hook and rod are also designed to provide stability to promote fusion. It has been determined that these products contain springs made of type 304 stainless steel instead of the specified titanium alloy.

Siemens Medical Solutions USA; Inc. March 18, 2014 Siemens syngo Dynamics – syngo Dynamics Picture Archiving and Communication System (PACS). Model 10091804; 10091805; 10091806; 10091807; 10091673 Potential patient data confusion. Improper handling of the error may cause two different patients to be displayed in syngo Dynamics. Images displayed for one patient and reporting system displayed for another patient; the possibility of misdiagnosis.

Teleflex Medical March 19, 2014 The Rush Endobronchial Tube set-Rusch Brochopart and Rusch Brochopart White include; but are not limited to; thoracic surgery; bronchial spirometry; implementation of endobronchial anesthesia; etc. The endobronchial tube allows ventilation and selective expansion or deflation of either lung. As the cuff expands to one side, the product may not be able to seal the right lung

Philips Medical Systems North America, Inc. March 19, 2014 Philips HeartStart Home and OnSite (HS1) Automated External Defibrillator (AED)-Philips HeartStart Home and OnSite (HS1) Automated External Defibrillator (AED). Product use: Models M5066A; M5067A; and M5068A are designed for cardiac arrest patients in the following conditions:-no response when shaking-abnormal breathing if in doubt; apply pad. It is recommended that anyone who may use HS1 attend a training course on the use of CPR/AED. If the person is an infant or child under eight years of age or weighs less than 55 lbs (25 kg); use a special infant/child cushion. If the child looks bigger/bigger; use an adult pad. Do not delay treatment to determine the child's exact age or weight. If in doubt; use adult pads. Model M5066A (for HS1 Onsite); M5067A (onsite); and M5068A (for HS1 Home). Philips is recalling the HeartStart Home and OnSite (HS1) automatic external defibrillator (AED) because one or two contact pins may be contaminated by residues from the welding process. This contamination may prevent adequate connection between the electrode cartridge and the AED. If the pad cartridge is in poor contact with the AED; the device may not be able to provide treatment in an emergency

Medical Information Technology; Inc. Mar-19-2014 MEDITECH Microbiology – MEDITECH Microbiology; Client Server Version 5.6; 5.65; 5.66; 5.67; 6.0; 6.05; 6.07; 6.1; 6.13 and 6.14. Integrated requisition; specimen processing; and patient information And the data in the Medical Information System (HCIS). Possibility of reporting incorrect results.

Philips Medical Systems North America Inc. March 19, 2014 Philips HeartStart FR3 Automatic External Defibrillator (AED)-Philips HeartStart FR3 Automatic External Defibrillator (AED); models 861388 and 861389. The HeartStart FR3 is a battery-powered automatic external defibrillator (AED) designed for first responders trained in basic life support (BLS); advanced life support (ALS); or emergency medical response plans authorized by other doctors. HeartStart FR3 is used to treat patients with suspected ventricular fibrillation (VF); the most common cause of sudden cardiac arrest (SCA); and certain ventricular tachycardia (VT). Both models use disposable defibrillator pads, suitable for potential victims of SCA, with the following symptoms:-unresponsiveness-unable to breathe normally if in doubt; apply the pad. The HeartStart FR3 is suitable for adults and children who are 55 lbs (25 kg) or over 8 years old. Models 861388 and 861389 are also suitable for children under 55 lbs (25 kg) or under 8 years of age, for use with the optional infant/child key. If the baby/child key is not available; or you are not sure about the child’s age or weight; do not delay treatment. Philip's is recalling the HeartStart FR3 automatic external defibrillator (AED) because of the printed circuit board (PCB); it contains the circuitry that powers the device; it may be separated from the electrical contacts that hold the board in place. If the PCB is separated from the electrical contacts; the AED may not be ready

Terumo Cardiovascular Systems, Inc. March 19, 2014 Sarns malleable two-stage venous return cannula – Sarns malleable two-stage venous return cannula; 28/38 Fr with 1/2" connector; 14.5" (37 cm) long Sarns expandable two-stage venous return catheter and Sarns two-stage venous return cannula are suitable for single-tube venous drainage from the right atrium and vena cava during treatment. These devices can be used for up to 6 hours. During the process inspection; Terumo Cardiovascular Systems (Terumo CVS) found exposed basket wires on certain batches of Sarns malleable two-stage venous return cannula and Sarns two-stage venous return cannula.

Terumo Cardiovascular Systems Inc. March 19, 2014 Sarns dual-stage venous return cannula-Sarns dual-stage venous return cannula; 34/46 Fr with 1/2" flared Sarns expandable dual-stage venous return catheter and Sarns dual-stage The venous return cannula is suitable for single-tube venous drainage from the right atrium and inferior vena cava during cardiopulmonary bypass surgery. These devices are suitable for use for up to 6 hours. During the procedure examination, Terumo Cardiovascular Systems (Terumo CVS) Exposed basket-shaped wires were found on the Sarns malleable two-stage venous return cannula and Sarns two-stage venous return cannula of the product batch.

Terumo Cardiovascular Systems, Inc. March 19, 2014 Sarns dual-stage venous return cannula-Sarns dual-stage venous return cannula; 32/40 Fr with 1/2" flared Sarns malleable dual-stage venous return catheter and Sarns dual-stage The venous return cannula is suitable for single-tube venous drainage from the right atrium and inferior vena cava during cardiopulmonary bypass surgery. These devices are suitable for use for up to 6 hours. During the procedure examination, Terumo Cardiovascular Systems (Terumo CVS) Exposed basket-shaped wires were found on the Sarns malleable two-stage venous return cannula and Sarns two-stage venous return cannula of the product batch.

Terumo Cardiovascular Systems Inc. March 19, 2014 Sarns malleable two-stage venous return cannula – Sarns malleable two-stage venous return cannula; 32/40 Fr with 1/2" connector; 15" (38 cm) The long Sarns expandable dual-stage venous return catheter and the Sarns dual-stage venous return cannula are suitable for single-tube venous drainage surgery from the right atrium and vena cava during treatment. These devices can be used for up to 6 hours. During the process inspection; Terumo Cardiovascular Systems (Terumo CVS) found exposed basket wires on certain batches of Sarns malleable two-stage venous return cannula and Sarns two-stage venous return cannula.

Terumo Cardiovascular Systems Inc. March 19, 2014 Sarns malleable two-stage venous return cannula – Sarns malleable two-stage venous return cannula; 28/38 Fr with 1/2" connector; 14.5" (37 cm) Long; X-coated Sarns malleable two-stage venous return catheter and Sarns two-stage venous return cannula are suitable for single-tube venous drainage from the right atrium and inferior vena cava during cardiopulmonary bypass surgery. These devices can be used for up to 6 hours. During the process inspection; Terumo Cardiovascular Systems (Terumo CVS) found exposed basket wires on certain batches of Sarns malleable two-stage venous return cannula and Sarns two-stage venous return cannula.

Terumo Cardiovascular Systems Inc. March 19, 2014 Sarns malleable two-stage venous return cannula – Sarns malleable two-stage venous return cannula; 34/46 Fr with 1/2" connector; 15" (38 cm) long Sarns expandable two-stage venous return catheter and Sarns two-stage venous return cannula are suitable for single-tube venous drainage from the right atrium and vena cava during treatment. These devices can be used for up to 6 hours. During the process inspection; Terumo Cardiovascular Systems (Terumo CVS) found exposed basket wires on certain batches of Sarns malleable two-stage venous return cannula and Sarns two-stage venous return cannula.

Terumo Cardiovascular Systems Inc. March 19, 2014 Sarns malleable two-stage venous return cannula – Sarns malleable two-stage venous return cannula; 34/46 Fr with 1/2" connector; 15" (38 cm) long ; Sarns malleable two-stage venous return catheter with X coating and Sarns two-stage venous return cannula are suitable for single-tube venous drainage from the right atrium and inferior vena cava during cardiopulmonary bypass surgery. These devices can be used for up to 6 hours. During the process inspection; Terumo Cardiovascular Systems (Terumo CVS) found exposed basket wires on certain batches of Sarns malleable two-stage venous return cannula and Sarns two-stage venous return cannula.

Ortho-Clinical Diagnostics March 19, 2014 VITROS Chemical White Reference Slide – VITROS Chemical White Reference Slide; White Correction Factor Slide (WCF); DT slide; 25 slides; part number J02315; Ortho-Clinical Diagnostics is manufactured in the United States; Inc. 100 Indigo Creek Drive; Rochester; NY 14626 — This product is a part/tool ​​used when performing correction factor adjustments on the VITROS chemical system. It does not have a 510(k) number. Because WCF slides are parts/tools; and not equipment for diagnostic testing; there is no intended use statement. The following summary is provided as a description/explanation of the WCF slides. The WCF slide is a component/tool ​​used in the adjustment procedure of the reflectometer correction factor to optimize the VITROS 250/350/5;1 FS/4600 chemical system and the VITROS 5600 Integrated optical calibration incorrect measurement value (0.3785) 460 The nm wavelength (filter) printed on the product carton may cause delays in the ability to obtain and report TBIL; Bu; BC; and derived test results. The correct measured value is 0.8658.

Convatec Inc. Mar-20-2014 Unomedical – SLC 2-way Standard Lubricious Coated14ch/FR 5/10ml/ccProduct Usage: Usage: Usage:Latex Lubricous Coated Foley Catheters Standard Catheters is mainly composed of a flexible lubricating coating latex tube, which contains A main drainage tube lumen and one or two small lumens constructed in the tube wall. A small lumen is used to inflate the retention balloon (available for 2-Way & 3-Way catheters). The second small lumen (only for 3-way catheters) is used for bladder irrigation. It was found that the lumen of the Medline sterile Foley catheter was blocked by too much lubricating coating material.

Stryker Instruments Division March 20, 2014 Hummer IV Microdebrider System-2.5 mm aggressive blade called sinus shaver; the device consists of a metal cutter and a plastic drive shaft, the drive shaft enters the metal supported by a plastic hub shell. Ear, nose and throat precision cutting machine; provocative; ESSxl Hummer 4; Rx OnlyIt is used for ear, nose and throat surgery and functions by rotating when adapting to mobile phones and consoles. Through rotation; cut the necessary tissue according to the user's requirements. The blade housing has an etching line guide, starting from a straight line, and with a scale from 1 cm to 7 cm in increments of 1 cm, as a guide for the doctor by indicating the distance the device is introduced into the surgical area. Stryker Instruments is voluntarily recalling single-use 2.5MM aggressive blades because the line on the affected part (P/N 5290-928-000; Lot #13280CG2) is a straight line without digital scales or markings. The line required for this part number includes a digital scale, from 1cm to 7cm.

Convatec Inc. Mar-20-2014 Unometical – SLC 3-way Standard Lubricant Coating 20Ch/Fr 30 mL/ccProduct Usage: Latex Lubricous Coated Foley Catheters The drainage lumen and one or two small lumens constructed on the tube wall. A small lumen is used to inflate the retention balloon (available for 2-Way & 3-Way catheters). The second small lumen (only for 3-way catheters) is used for bladder irrigation. It was found that the lumen of the Medline sterile Foley catheter was blocked by too much lubricating coating material.

Convatec Inc. Mar-20-2014 Medline – Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces Model DNYD11914Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter is mainly composed of a flexible lubricating coating latex tube, which contains a main drainage The lumen and one or two small lumens are constructed on the tube wall. A small lumen is used to inflate the retention balloon (available for 2-Way & 3-Way catheters). The second small lumen (only for 3-way catheters) is used for bladder irrigation. It was found that the lumen of the Medline sterile Foley catheter was blocked by too much lubricating coating material.

Remel Inc March 20, 2014 Oxoid vancomycin drug sensitive tablets; 30 micrograms. – Oxoid vancomycin 30 micrograms; each cartridge contains 50 magnetized disks; CT0058B. The company name on the label is Oxoid Ltd.; Basingstoke; Hampshire; England. Semi-quantitative agar diffusion test method for in vitro susceptibility test. Some discs may not be impregnated with antibiotics.

Convatec Inc. Mar-20-2014 Medeco – Curion CuriStay Nelaton CH – 14 2-W Hydrogel Coated (Latex) 5-10 mLProduct Usage: Latex Lubricous Coated Foley Catheters A primary drainage lumen and one or two secondary lumens constructed on the tube wall. A small lumen is used to inflate the retention balloon (available for 2-Way & 3-Way catheters). The second small lumen (only for 3-way catheters) is used for bladder irrigation. It was found that the lumen of the Medline sterile Foley catheter was blocked by too much lubricating coating material.

Convatec Inc. March 20, 2014 JMS-JMS; Japan; 3 way; 20 FR 10 mL Product use: Foley catheter with latex lubrication coating The standard catheter is mainly composed of a flexible lubricating coating latex tube, the tube contains a main Drainage lumen and one or two small lumens built in the tube wall. A small lumen is used to inflate the retention balloon (available for 2-Way & 3-Way catheters). The second small lumen (only for 3-way catheters) is used for bladder irrigation. It was found that the lumen of the Medline sterile Foley catheter was blocked by too much lubricating coating material.

Convatec Inc. Mar-20-2014 TORAY –'TORAY' Hydrocoat Foley Catheter12 x104.00 mm Fr x mLProduct Usage: Latex Lubricous Coated Foley Catheters The lumen and one or two small lumens are constructed on the tube wall. A small lumen is used to inflate the retention balloon (available for 2-Way & 3-Way catheters). The second small lumen (only for 3-way catheters) is used for bladder irrigation. It was found that the lumen of the Medline sterile Foley catheter was blocked by too much lubricating coating material.

Clarity Medical Systems Inc March 20, 2014 Halogen lamp components in the RetCam 3 system – Halogen lamp components in the RetCam 3 system – Clarity Medical Systems; Company; Pleasanton; CA. General ophthalmic imaging including retina; cornea and External imaging. Photo records of pediatric eye diseases including retinopathy of prematurity. Screen for premature birth or type 2 rethreshold retinopathy that requires ROP treatment. A batch of halogen lamps may fail earlier than the lamp's expected life, which may cause damage to the internal electrical components limited to the RetCam 3 computer module.

Philips Medical Systems North America Inc. Philips model EPIQ 5 ultrasound system on March 20, 2014. – Philips EPIQ 5 ultrasound system. Used for diagnostic ultrasound imaging and fluid flow analysis. Catalog number 795200/795201/795202/795204/795205 / 795206EPIQ is used for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results is used to assist in the diagnosis of presence; the location and severity of heart or blood vessel stenosis. Philips EPIQ 5 and 7 ultrasonic systems have detected problems. If you use high pulse repetition frequency (HPRF) with multiple sample volume gates, the system will report an incorrect Doppler velocity. When using manual spectral Doppler tracking to display the high pulse repetition frequency (HPRF) in the zoom speed scale; the speed in the speed result table may be exaggerated

Philips Medical Systems North America Inc. Philips EPIQ 7 ultrasound system on March 20, 2014. – Philips EPIQ 7 ultrasound system. Used for diagnostic ultrasound imaging and fluid flow analysis. Catalog number 795200/795201/795202/795204/795205 / 795206EPIQ is used for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results is used to assist in the diagnosis of presence; the location and severity of heart or blood vessel stenosis. Philips EPIQ 5 and 7 ultrasonic systems have detected problems. If you use high pulse repetition frequency (HPRF) with multiple sample volume gates, the system will report an incorrect Doppler velocity. When using manual spectral Doppler tracking to display the high pulse repetition frequency (HPRF) in the zoom speed scale; the speed in the speed result table may be exaggerated b

Golden Technology; Inc. March 20, 2014 Golden Buzzaround XL – Product use of Buzzaround XL scooter: The front and rear locking of the mobile Buzzaround XL scooter may be accidentally detached due to improper installation of the front alignment cup and the rear alignment screw.

Biotechnology; Inc. Mar-20-2014 Intramedullary Bone Saw – Part 475620 Intramedullary Bone Saw CAM component size is 12 mm; a unique and unique clinical instrument for correcting leg length; or the difference in rotation of the femur. The label of the intramedullary bone saw for a particular batch is incorrect. The saw blade assembly is recognized as a CAM assembly.

Biotechnology; Inc. Mar-20-2014 intramedullary bone saw-part 475630; intramedullary bone saw; cam component size 14 mm; Biomet intramedullary bone saw is a unique and exclusive clinical instrument used to correct leg length; or The rotation difference of the femur. The label of the intramedullary bone saw for a particular batch is incorrect. The saw blade assembly is recognized as a CAM assembly.

Biotechnology; Inc. Mar-20-2014 intramedullary bone saw-part 475625; intramedullary bone saw; cam assembly size 13 mm; Biomet intramedullary bone saw is a unique and exclusive clinical instrument used to correct leg length; or The rotation difference of the femur. The label of the intramedullary bone saw for a particular batch is incorrect. The saw blade assembly is recognized as a CAM assembly.

General Electric Healthcare; LLC March 20, 2014 GE Healthcare Optima CT580/Discovery CT590RT scanner-GE Healthcare Optima CT580/Discovery CT590RT scanner running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of computed tomography systems are designed to produce cross-sectional images of the body that cross the X-ray transmission data taken at different angles and planes through computer reconstruction; including axial; film; spiral (volume); all age groups Gated (respiratory and cardiac) acquisition of the patient. Due to software issues related to the head scanning protocol used on Optima CT580 or Discovery CT590RT scanners, GE Healthcare recently realized a potential safety issue. Potentially dangerous situations can occur during a CT head scan, resulting in new rare artifacts that may hide the pathology. When using big head and big head SFOV; apply iterative bone option (IBO)

Zimmer; Inc. March 20, 2014 Apollo "Knee System-Apollo" Knee System: APOLLO PATELLA SZ0 28MM R received a complaint about discolored All Poly tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Natural-Knee II posterior stabilization (PS) condyle tibial insert – Natural-Knee II posterior stabilization (PS) condyle tibial insert: NK II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS INS TIB SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZN-K II CONS PS TIB INS SZ discolors all Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Natural-Knee II System – Natural-Knee II SystemULTRA CONG INS LT SZA/9MMULTRA CONG INS LT SZA/13MULTRA CONG INS LT SZA/19MULTRA CONG INS RT SZA/9MMULTRA CONG INS RT SZA/ 11M RT SZA/13MULTRA CONG INS RT SZA/19MULTRA CONG INS LT SZB/13MULTRA CONG INS LT SZB/16MULTRA CONG INS RT SZB/19MULTRA CONG INS RT SZB/22MNKII ROT PLTFM U/C INS; 9NKII ROT PLTFM U/C 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1NKII ROT PLTFM U/C INS; 1ALL POLY CONG TIB LT SZ00ALL POLY CONG TIB LT SZ0/ALL POLY CONG TIB LT SZ0/ALL POLY CONG TIB RT SZ0/ALL POLY CONG TIB RT SZ0/ALL POLY CONG TIB LT SZ1/ALL POLY CONG TIB LT SZ1 TIB RT SZ1/ALL POLY CONG TIB RT SZ1/ALL POLY CONG TIB RT SZ1/ALL POLY CONG TIB LT SZ2/ALL POLY CONG TIB LT SZ2/ALL POLY CONG TIB LT SZ2/ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB RT SZ2/ALL POLY CONG TIB RT SZ2/ALL POLY CONG TIB RT SZ2/ALL POLY CONG TIB LT SZ3/ALL POLY CONG TIB LT SZ3/ALL POLY CONG TIB LT SZ3/ALL POLY CONG TIB RT SZ3/ALL POLY CONG TIB RT SZ3/ALL POLY CONG TIB RT SZ3/ALL POLY CONG TIB LT SZ4/ALL POLY CONG TIB LT SZ4/ALL POLY CONG TIB RT SZ4/ALL POLY CONG TIB RT SZ4/ALL POLY CONG TIB RT SZ5/PS TIB INS RT SZ1/ 2 16MMPS TIB INS RT SZ1/2 19MMPS TIB INS LT SZ00/0 19MMPS TIB INS RT SZ00/0 11MMPS TIB INS RT SZ00/0 16MM I have received a complaint about discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Natural-Knee/Apollo" Knee – Natural-Knee/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEEM/B PAT SZ1 NATURAL-KNEEM/B PAT SZ2 NATURAL-KNEE All-Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Natural-Knee II Restraint Knee System – Natural-Knee II Restraint Knee System NKII CCK TIB INS SZ00/0-LNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ3-5 -LNKII CCK TIB INS SZ00 /0-RNKII CCK TIB INS SZ3-5 -RNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ3-5 -LNKII CCK TIB INS SZ00/0-RNKII CCK TIB INS SZ1/2-RTNKII CCK TIB INS SZ3-5 -RNKII CCK TIB INS SZ00/0-LNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ3-5 -LNKII CCK TIB INS SZ00/0-RNKII CCK TIB INS SZ3-5 -RNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ3-5 -LNKII CCK TIB INS SZ00/0-RNKII CCK TIB INS SZ3-5 -RNKII CCK TIB INS SZ00/0-LNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ00 /0-RNKII CCK TIB INS SZ1/2-RTNKII CCK TIB INS SZ1/2-LFNKII CCK TIB INS SZ3-5 -LNKII CCK TIB INS SZ00/0-RNKII CCK TIB INS SZ1/2-RTNKII CCK TIB INS SZ00/0 -LNKII CCK TIB INS SZ00 /0-RA received a complaint about the discoloration of All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Natural-Knee II System – Natural-Knee II System: POLY ULTRA TIB LT SZ00/9MPOLY ULTRA TIB LT SZ0/9MMPOLY ULTRA TIB LT SZ0/19MPOLY ULTRA TIB RT SZ0/13MPOLY SZ0/13MPOLY SZ0/9MPOLY ULTRA TIB16 POLY ULTRA TIB LT SZ1ALL POLY ULTRA TIB RT SZ1ALL POLY ULTRA TIB LT SZ2ALL POLY ULTRA TIB LT SZ2ALL POLY ULTRA TIB RT SZ2ALL POLY ULTRA TIB LT SZ3ALL POLY ULTRA TIB RT SZ5 POLY POLY POLY POLY SZ5 The complaint. The root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Apollo "Knee System-Apollo" Knee System: PS TIB INS SZ0/16MM APOLLPS TIB INS SZ0/19MM APOLLPS TIB INS SZ0/22MM APOLLPS TIB INS SZ1/16MM APOLLPS TIB INS SZ2 /16MM APOLLPS SZ2/22MM APOLLPS TIB INS SZ3/16MM APOLLPS TIB INS SZ3/19MM APOLLPS TIB INS SZ4/9MM APOLLPS TIB INS SZ4/11MM APOLLPS TIB INS SZ4/13MM APOLLPS TIB INS SLP4/14MM APOLLPS TIB INS SLP4/14MM APOLLPS TIB INS SLP4/14MM APOLLPS TIB INS SZ4/14MM APOLLPS TIB INS 22MM APOLLPS TIB INS SZ5/9MM APOLLOPS TIB INS SZ5/19MM APOLL received a complaint about discoloration of All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Natural-Knee II Unicompartmental Knee System – Natural-Knee II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm Received about discoloration all-poly tibia The complaint. The root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Apollo Knee Tibial Floor/Knee Tibial Inserts-Apollo Knee Tibial Floor/Knee Tibial Inserts: CONG TIB INS SZ0/19MM APOCONG TIB INS SZ0/22MM APOCONG TIB INS SZ1/9MM APOLCONG TIB 1MMOC1/ TIB INS SZ1/19MM APOCONG TIB INS SZ2/13MM APOCONG TIB INS SZ2/19MM APOCONG TIB INS SZ3/9MM APOLCONG TIB INS SZ3/13MM APO has received a complaint about discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Natural-Knee Congruent Tibial Insert with Screw – Natural-Knee Congruent Tibial Insert with Screw:SF-CON TIB INS LT SZ1/2 1SF-CON TIB INS RT SZ1/2 9SF-CON TIB INS RT SZ3 /4/5 received a complaint about the discoloration of All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 MOST Options"System – MOST Options" System (MOST)HINGED TIB INS SZ 1 16MMHINGED TIB INS SZ 4 6MM MHINGED TIB INS SZ 4 9MM MHINGED TIB INS SZ 4 16MMMOST PROX TIB INS SZ 6 For discolored full poly tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Natural-Knee II System – Natural-KneeN-K II DOMED ALL-POLY PAT; SZ0N-K II dome ALL-POLY PAT; SZ1 received a complaint about discolored All Poly Tibia . Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Apollo" Revision/Constrained Knee System – Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSERSZ1-11MM AK CCK TIB INSERSZ1-16MM AK CCK TIB INSERSZ1-22MM ERSAK CCK TIB INSERSZ1-11MM AK CCK TIB INSERSZ2-11MM AK CCK TIB INSERSZ2-13MM AK CCK TIB INSERSZ2-16MM AK CCK TIB INSERSZ2-22MM AK CCK TIB INSERSZ2-30MM AK CCK TIB INSERSZ3-16MM AK CCK TIB INSERSZ3-16MM AK CCK TIB INSERSZ2-16 TIMM AKERSZ2-16MM AK CCK TIB 30MM TIB INSERSZ4-13MM AK CCK TIB INSERSZ4-16MM AK CCK TIB INSERSZ5-11MM AK CCK TIB INSER Received a complaint about discolored All-Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Natural-Knee II-Single-compartment knee prosthesis-Natural-Knee II-Single-compartment knee prosthesis: CONG TIB INS SZ1/2 9MM UNCONG TIB INS SZ1/2 11MM UCONG TIB INS SZ1/2 TIB3MM UCZ /4 9MM UNCONG TIB INS SZ3/4 11MM UCONG TIB INS SZ3/4 13MM UCONG TIB INS SZ 5/6 9MM UCONG TIB INS SZ5/6 11MM UCONG TIB INS SZ5/6 13MM UA Complaints of discoloration. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Zimmer; Inc. Mar-20-2014 Gender Solutions "Natural-Knee Flex System – Gender Solutions" Natural-Knee Flex System: NK FLEX MBACK SZ 0 PATN-K FLEX MBACK SZ 1 PATN-K FLEX MBACK SZ 2 PAT received Complaint of discoloration of the full poly tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. Since the machined parts are stored in transparent containers exposed to artificial light for up to six years before the equipment is inertly packaged and sterilized, the oxidation process is carried out ahead of schedule.

Bock; Otto; Orthopedic Ind; Inc March 21, 2014 Aerial wheelchair mat-Otto Bock aerial and aerial activity wheelchair mat. Part number: SK757 476C00=SK701; 476C00=SK702; 476C00=SK703; 476C00=SK704; 476C00=SK705; 476C00=SK706; 476C00=SK707; The following material numbers are not distributed in the United States: 476C00=SK751; 476C00=SK752; 476C00 =SK753; 476C00=SK754; 476C00=SK755; 476C00=SK756; 476C00=SK757. Ottobock is recalling all aerial and aerial mobility wheelchair mats in specific material numbers. During internal testing; it was found that after cleaning at high temperatures, the mat has a small risk of flammability. The mat should be returned to Ottobock or destroyed.

AMS diagnosis; LLC March 21, 2014 AMS Uric Acid-AMS URIC ACID is used for in vitro quantitative determination of serum uric acid. Quantitative determination of serum uric acid. Marketing equipment beyond 510(k) requirements

AMS diagnosis; LLC March 21, 2014 AMS AST-AMS AST is used for in vitro quantitative determination of AST in serum. Quantitative determination of AST in serum. Marketing equipment beyond 510(k) requirements

AMS diagnosis; LLC March 21, 2014 AMS BUN Urea Nitrogen-AMS BUN Urea Nitrogen is used for the in vitro quantitative determination of serum urea nitrogen. Quantitative determination of Bun in serum. Marketing equipment beyond 510(k) requirements

Mevion Medical System; Inc. March 22, 2014 MEVION – MEVION S250; System; Radiotherapy; Charged particles; Medical products used for proton radiotherapy. Use: Proton radiotherapy performs rotation correction on one or more treatment areas. Geometric positioning errors may occur

Siemens Medical Solutions United States; Inc March 22, 2014 Siemens – AXIOM Artis Systems Product use: Artis zee is a series of dedicated angiography systems, developed for single-plane and bi-plane diagnostic imaging and interventional surgery, including; but not Limited to; children and obese patients. Some devices of the AXIOM Artis system use flat detector cooling devices, and their connectors are not suitable and may leak; cause system failures and may exit the gantry system.

Velocity Medical Solutions; LLC DICOM on March 25, 2014-The total dose of DICOM export format and Velocity v3.0.0. An independent software product that provides cancer care specialists (physicists; physicists; dosiologists; etc.) with a way to compare medical imaging data from multiple DICOM-compliant imaging mode sources. It allows display; annotation; volume rendering; registration and fusion of medical images as an aid during the use of diagnostic radiology; oncology; radiotherapy planning and other medical specialties. Anomaly detected: Under certain conditions; when importing doses from Velocity, the total dose created by Velocity replaces the calculated dose of the approved plan in Eclipse.

Spacelab Healthcare; LLC March 25, 2014 Spacelabs Healthcare G2 Clinical Visit CD – Spacelabs Healthcare G2 Clinical Visit mislabeled PN CD: 063-1829-11 Rev A and update kit; PN: 040-1565-10. Used to install ICS G2 Clinical Access software on the hospital personal computer. Spacelabs has voluntarily recalled the G2 Clinical Access software CD because the program installed on the Clinical Access CD is incorrect, which will prevent customers from installing Clinical Access.

Teleflex Medical Mar-25-2014 Weck – Weck Vista"; universal laparoscopic port; size 5/10mmx100mm; product use: endoscope and accessories are used to provide access; lighting; and allow observation or manipulation of body cavities; hollow organs The equipment; and the canal. Received complaints about the leakage of the insufflation gas through the device; this may cause difficulty or delay in the completion of laparoscopic surgery.

Teleflex Medical Mar-25-2014 Weck – 5/10/12 Weck Vista" Universal Balloon Open Access Port? Standard length (70mm); product use: endoscope and accessories are used to provide access; lighting; and allow observation Or manipulate body cavities; hollow organs; and canals. Receive complaints about the leakage of insufflation gas through the device; this may cause difficulty or delay in completing laparoscopic surgery.

Teleflex Medical Mar-25-2014 Weck – Weck Vista" universal laparoscopic port; size 5/10/12mmx100mm; product use: endoscope and accessories are a device used to provide access; lighting; and allow observation or manipulation of body cavities Hollow organs; and canals. Complaints about leakage of insufflation gas through the device have been received; this may cause difficulties or delays in the completion of laparoscopic surgery.

Teleflex Medical Mar-25-2014 Weck – 5/10 mm Weck; Vista" optical bladeless laparoscope access port; product use: endoscope and accessories are used to provide access, illumination; and allow observation or manipulation of body cavities, Equipment for hollow organs and canals. I have received complaints about leakage of insufflation gas through the endoscope; this may cause difficulties or delays in the completion of laparoscopic surgery.

Teleflex Medical Mar-25-2014 Weck – 5/10/12 mm Weck Vista" optical bladeless laparoscope access port; product use: endoscope and accessories are used to provide access, illumination and allow observation or manipulation of body cavities The equipment; hollow organs; and canals. Complaints have been received about the leakage of the insufflation gas through the device; this may cause difficulties or delays in completing the laparoscopic procedure.

Teleflex Medical Mar-25-2014 Weck – 5/10/12 Weck Vista" Universal Balloon Open Access Port? Long Length (100mm); Product use: Endoscope and accessories are used to provide access, lighting and allow observation or Manipulate body cavities; hollow organs; and canals. Receive complaints about leakage of insufflation gas through the device; this may cause difficulties or delays in completing laparoscopic surgery.

Teleflex Medical Mar-25-2014 Weck – 10mm Weck Vista" Cannula-only; Teleflex Medical; Product use: Endoscope and accessories are used to provide access; lighting; and allow observation or manipulation of body cavities; hollow organs; and collection To complaints about gas leakage through the device; this may cause difficulties or delays in the completion of laparoscopic surgery.

Teleflex Medical Mar-25-2014 Weck – 5/10 Weck Vista" Universal Balloon Open Access Port – Long Length (100mm); Product use: Endoscope and accessories are used to provide access; lighting; and allow observation or operation The body cavity of the device; the hollow organ; and the canal. I have received complaints about the leakage of the gas blown through the device; this may cause difficulties or delays in the completion of the laparoscopic surgery.

Teleflex Medical Mar-25-2014 Weck – Weck Vista" universal laparoscopic port; size 5/10/12mmx125mm; product use: endoscope and accessories are a device used to provide access; lighting; and allow observation or manipulation of body cavities Hollow organs; and canals. Complaints about leakage of insufflation gas through the device have been received; this may cause difficulties or delays in the completion of laparoscopic surgery.

Teleflex Medical Mar-25-2014 Weck – 5/10 mm Weck; Vista" universal cannula; Teleflex Medical; Product use: Endoscope and accessories are used to provide access, lighting and allow observation or manipulation of body cavities and hollow organs And the canal equipment. Received complaints about the leaking equipment of the insufflation gas through the pipeline; this may cause difficulties or delays in completing the laparoscopic surgery.

Teleflex Medical Mar-25-2014 Weck – 12mm Weck Vista" Cannula-only; Teleflex Medical; Product use: Endoscope and accessories are used to provide access; lighting; and allow observation or manipulation of body cavities; hollow organs; and collection To complaints about gas leakage through the device; this may cause difficulties or delays in the completion of laparoscopic surgery.

Teleflex Medical Mar-25-2014 Weck – 5/10 Weck Vista" Universal Balloon Open Access Port – standard length (70mm); product use: endoscope and accessories are used to provide access; lighting; and allow observation or operation The body cavity of the device; the hollow organ; and the canal. I have received complaints about the leakage of the gas blown through the device; this may cause difficulties or delays in the completion of the laparoscopic surgery.

Teleflex Medical Mar-25-2014 Weck – 5/10 Weck Vista" Universal Balloon Open Access Port? Short Length (53mm); Product use: Endoscope and accessories are used to provide access; lighting; and allow observation or operation The body cavity of the device; the hollow organ; and the canal. I have received complaints about the leakage of the gas blown through the device; this may cause difficulties or delays in the completion of the laparoscopic surgery.

Synthetic; Inc. March 25, 2014 Synthetic 2.7mm LCP Ulna Osteotomy System-Drill template and saw guide for ulna osteotomy system. Used to fix fractures; osteotomies; disunion; replantation; and fusion of small bones and small bone fragments; including osteopenia in the ulna. The drilling template and saw guide of the ulnar osteotomy system may jam; bend; or the screw connecting the saw guide to the drilling template is broken or jammed; bent; or the Kirschner wire breaks during the fixation of the drilling template .

Teleflex Medical Mar-25-2014 Weck – 5/10/12MM X 100MM Weck Vista" UNIVERSAL CONE OPEN ACCESS; Product use: Endoscope and accessories are a device used to provide access; lighting; and allow observation or manipulation of body cavities Hollow organs; and canals. Complaints about leakage of insufflation gas through the device have been received; this may cause difficulties or delays in completing the laparoscopic procedure.

Teleflex Medical Mar-25-2014 Weck – 5/10/12 mm Weck Vista" universal cannula; product use: endoscope and accessories are used to provide access; lighting; and allow observation or manipulation of body cavities; hollow organs; Received complaints about leakage of gas injected through the device; this may cause difficulty or delay in completion of laparoscopic surgery.

TriVascular; Inc. March 26, 2014 Ovation Prime Abdominal Stent Graft System – Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular; Inc. 3910 Brickway Blvd. Santa Rosa; CA 95403 TriVascular Ovation Prime Abdominal Stent Graft System is an intravascular device delivered through a small diameter catheter for the treatment of abdominal aortic aneurysms (AAA). The stent graft is designed to rearrange the diseased vasculature; provide an intravascular blood tube that isolates the aneurysm from the high-pressure blood flow; thereby reducing the risk of rupture. The stent graft is a modular configuration consisting of aortic body parts; iliac limbs; and iliac bone extension as needed. Communicate with European doctor users of the Ovation Prime Abdominal Stent Graft System and notify them of the changes to the instructions.

Teleflex Medical March 26, 2014 suture; non-absorbable; synthetic; polyamide-suture; non-absorbable; synthetic; polyamide; sterile; accept only; product use: non-absorbable polyamide surgical suture is not Absorbable; sterile; flexible thread made of long-chain aliphatic polymers nylon 6 and nylon 6; 6, suitable for soft tissue approximation. These products were recalled because they did not meet the minimum needle connection strength requirements.

Teleflex Medical March 26, 2014 suture; non-absorbable; synthetic; polyethylene-suture; non-absorbable; synthetic; polypropylene; sterile; accept only; product use: non-absorbable polypropylene surgical suture as monofilament ; Non-absorbable; sterile; flexible thread made of long-chain polyolefin polymer called polypropylene, suitable for soft tissue approximation. These products were recalled because they did not meet the minimum needle connection strength requirements.

Teleflex Medical March 26, 2014 suture; non-absorbable; silk; sterile-suture; non-absorbable; silk; sterile; accept only; product use: natural non-absorbable silk surgical suture is non-absorbable; sterile ; Flexible multifilament thread composed of organic protein called fibroin. This protein is derived from the domesticated species of Bombyx mori (Bombyx mori). Natural non-absorbable silk surgical sutures are suitable for soft tissue approximation. Natural non-absorbable silk surgical sutures meet the monograph requirements of the United States Pharmacopeia (USP) for non-absorbable surgical sutures (Class I). Natural non-absorbable silk surgical sutures can be woven or twisted; it can be provided uncoated or coated; it may be undyed or dyed with color additives listed by the FDA. These products were recalled because they did not meet the minimum needle connection strength requirements.

Teleflex Medical March 26, 2014 suture; absorbable; synthetic; polyglycolic acid. – Suture; Absorbable; Synthetic; Polyglycolic acid; Sterile; Accept only; Product use: Non-absorbable polypropylene surgical suture is monofilament; Non-absorbable; Sterile; Made of long-chain polyolefin called polypropylene Flexible thread made of polymer, suitable for soft tissue approximation. These products were recalled because they did not meet the minimum needle connection strength requirements.

Teleflex Medical sutured on March 26, 2014; non-absorbable; synthetic; polyethylene. – Sutures; non-absorbable; synthetic; polyethylene; sterile; accept only; product use: non-absorbable polyethylene terephthalate surgical sutures are multifilament; non-absorbable; sterile; made of high molecular weight fibers Manufactured flexible thread; long chain; linear polyester with cyclic aromatic ring as a whole component, suitable for soft tissue approximation. These products were recalled because they did not meet the minimum needle connection strength requirements.

Teleflex Medical March 26, 2014 Suture; non-absorbable; steel; monofilament and multifilament; sterile-suture; non-absorbable; steel; monofilament and multifilament; sterile; accept only; product use: smooth or A threaded metal bone fixation fastener is a device used for implantation, consisting of a hard wire segment or a rod made of alloy; such as cobalt-chromium-molybdenum and stainless steel; this may be smooth on the outside; fully or partially threaded ; Straight or U-shaped; and may be blunt; pointed; or formed; head with a groove at the end. It can be used for the fixation of fractures; for bone reconstruction; as a guide pin for inserting other implants; or it can be implanted through the skin to apply tension (traction) to the skeletal system. These products were recalled because they did not meet the minimum needle connection strength requirements.

Abbott Point Of Care Inc. March 27, 2014 i-STAT G3 Kit – i-STAT G3 Kit pH; pCO2 and pO2 measurements are used for diagnosis; monitoring and treatment of respiratory disorders and metabolic and respiratory acid-based disorders. Abbott Point of Care has determined that some individual patient results generated using i-STAT G3 kit batch N13183 may show incorrect results of increased PCO2 and decreased pH.

Medtronic Vascular; Inc. Mar-27-2014 FIBERNET embolization protection system: recommended vessel diameter 3.5 0 5.0 mm – FIBERNET embolization protection system: recommended vessel diameter 3.5 0 5.0 mm; maximum guidewire diameter: only 0.014 inches (0.36 mm) Rx; sterile; manufactured by: Invatec SPA; 25030 Roncadere; Italy; manufacturer: Medtronic Inc. Minneapolis; MN 55432. The FiberNet embolic protection system is designated as a guide wire and embolic protection system to capture and remove The embolic material (thrombus/fragment) in the carotid artery during percutaneous transluminal intervention, the reference blood vessel diameter is 3.5 mm to 7.0 mm. Medtronic is recalling a specific batch number subset of the FIBERNET Embolic Protection System (EPS), where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and may subsequently remain on the FIBERNET EPS.

Medtronic Vascular; Inc. Mar-27-2014 FIBERNET Embolic Protection System: Recommended vessel diameter 5.0 -6.0 mm – FIBERNET Embolic Protection System: Recommended vessel diameter 5.0 -6.0 mm; Maximum guide wire diameter: only 0.014 inches (0.36 mm) Rx; sterile; manufactured by: Invatec SPA; 25030 Roncadere; Italy; manufacturer: Medtronic Inc. Minneapolis; MN 55432. The FiberNet embolic protection system is designated as a guide wire and embolic protection system to capture and remove The embolic material (thrombus/fragment) in the carotid artery during percutaneous transluminal intervention, the reference blood vessel diameter is 3.5 mm to 7.0 mm. Medtronic is recalling a specific batch number subset of the FIBERNET Embolic Protection System (EPS), where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and may subsequently remain on the FIBERNET EPS.

Medtronic Vascular; Inc. Mar-27-2014 FIBERNET Embolic Protection System: Recommended vessel diameter 6.0 -7.0 mm – FIBERNET Embolic Protection System: Recommended vessel diameter 6.0 -7.0 mm; Maximum guide wire diameter: only 0.014 inches (0.36 mm) Rx; sterile; manufactured by: Invatec SPA; 25030 Roncadere; Italy; manufacturer: Medtronic Inc. Minneapolis; MN 55432. The FiberNet embolic protection system is designated as a guide wire and embolic protection system to capture and remove The embolic material (thrombus/fragment) in the carotid artery during percutaneous transluminal intervention, the reference blood vessel diameter is 3.5 mm to 7.0 mm. Medtronic is recalling a specific batch number subset of the FIBERNET Embolic Protection System (EPS), where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and may subsequently remain on the FIBERNET EPS.

ECG; Inc. Mar-27-2014 Catheter Introducer – Morph AccessPro Steerable Introducer; 6F Introducer; 90 cm working length: single use only. BioCardia; Inc. San Carlos; CA 94070 BioCardia Morph AccessPro is designed to provide access through medical devices as a balloon dilatation catheter; guide wires or other therapeutic devices that can be introduced into the peripheral vasculature. Firm discovered that there may be particles in the lumen of the Morph Access Pro Steerable Introducer; this may cause an embolic event.

Siemens Medical Solutions United States; Inc Mar-27-2014 Siemens – Siemens Artis Q and Artis Q biplane system product use: Interventional X-ray X-ray tube failure may cause X-ray imaging of Artis Q and Artis Q biplane system Lost, the flat detector is 40 HDR (large size 30×40).

ECG; Inc. Mar-27-2014 Catheter Introducer – Morph AccessPro Steerable Introducer; 6F Introducer; 45 cm working length is for single use only. BioCardia; Inc. San Carlos; CA 94070 BioCardia Morph AccessPro is designed to provide access through medical devices as a balloon dilatation catheter; guide wires or other therapeutic devices that can be introduced into the peripheral vasculature. Firm discovered that there may be particles in the lumen of the Morph Access Pro Steerable Introducer; this may cause an embolic event.

Bard Access Systems March 27, 2014 PowerPort Slim implantable port – PowerPort Slim implantable port; suitable for the treatment of patients who require repeated access to the vascular system. Product Code: 1716000; 1716070 Bard Access Control Systems; Inc. has notified customers of label discrepancies involving PowerPort Slim Implantable Port 1716000; 1716070, where the label states that the implantable port contains silicone suture plugs; however, approximately 23% of the affected batches The device has a PowerPort Slim titanium implantable port and no silicone suture plug.

Bio-Rad Laboratory; Inc. Mar-27-2014 D-10" Hemoglobin Test System-D-10" Hemoglobin Test System; Model: 220-0220 Manufacturer: Bio-Rad Laboratories; Inc. 4000 Alfred· Nobel Driving Hercules; CA 94545D-10 Hemoglobin Test System is a single module designed for hemoglobin analysis in medium-scale laboratories. D-10 is a fully integrated sample dilution system; hemoglobin processing and analysis; designed for specific Bio-Rad kits. D-10 uses a dedicated software system for instrument control; data collection and analysis. In rare cases, the D-10 software may generate additional results by copying the results of the previous sample and the sample ID/injection number of the next sample.

RAYSEARCH LABORATORIES AB March 28, 2014 RayStation – Radiation Therapy Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plan provides treatment unit setting parameters and an estimate of the expected dose distribution during the proposed treatment period; it can be used for treatment after review and approval by the intended user. Due to a program error, RaySearch Laboratories recalled their independent software for radiotherapy treatment planning system.

Submit as follows: Food and Drug Administration (FDA), News Well, Recall, Regulatory/Compliance

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