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List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 December 2021

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Model: 92 articles were affected, see list in FSN

BVI Malosa Single Use Instrument Procedure Packs

Model: PATHFILE STER 25MM/013; PROTAPER GOLD F1 21MM STER; PROTAPER GOLD F2 21MM STER; PROTAPER GOLD F2 25MM STER; PROTAPER GOLD F2 31MM STER; PROGLIDER 6FILE STERILE 25MM MHRA reference: 2021/012/015/701/016

Dorc: EFTIAR Octane, Vials and Syringes, 5 ml and 7 ml

Model: Carestation 750 - Carestation 750c

Model: Liko M220 – model 2050010 & M230 – model 2050015 (serial number 5361393-5362761)

Picture archiving and communication system (PACS)

Model: Enhanced Viewer (EV) and InteleViewer (IV)

Model 1104 - follow-up FSN (FA944) - Update on failure rates and recommendation

Model: TJF-Q170V & TJF-Q190V & TJF-Q290V Duodenovideoscopes

Orthopaedic surgical instruments - insertion/extraction tool

Model: 6001-0010, 6001-001C, 6002-0010, 6002-001C, 6003-0020, 6003-002C, 6003-0050, 6003-005C, 6004-0010, 6004-001C

Model: X80, X100, X150, X200, X300

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