Field Safety Notices: 20 to 24 December 2021

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

Overview

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.

Latest FSNs

View the latest FSNs

View a list of FSNs published since January 2020

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

Abbott FSN 241221: HT Command 18 ST Guide Wire

FSN 241221

Vascular cannula/catheter accessories

MHRA reference: 2021/012/017/701/017

Abbott FA-AM-DEC2021-263: Alinity M System

06 December 2021

IVDs, clinical chemistry

Model: Instrumentation/ Platform

MHRA reference: 2021/012/008/701/055

Abbott Molecular: Alinity M System

06 December 2021

IVDs, clinical chemistry

Model: Alinity m system

MHRA reference: 2021/012/008/701/056

B Braun: Monoplus Violet 1 (4)150CM HRT40S(M)LOOP

15 December 2021

Sutures

MHRA reference: 2021/012/016/601/506

Batec: Mobility

01 December 2021

Wheelchairs, powered

Model: 92 articles were affected, see list in FSN

MHRA reference: 2021/012/021/487/011

Beaver Visitec International: Xstar and CustomEyes

BVI Malosa Single Use Instrument Procedure Packs

Surgical instruments, non-articulated cutting

Model: 373809 and 588221

MHRA reference: 2021/012/020/291/001

Boston Scientific: Tome/Autotome RX Family

16 December 2021

Surgical instruments, minimal access

MHRA reference: 2021/012/022/487/001

Dentsply Sirona: Pathfile; Proglider; Protaper Gold

December 2021

Dental appliances / instruments

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

15 December 2021

Injectable ophthalmic fluids

MHRA reference: 2021/012/022/487/005

Drager: Fabius MRI

December 2021

Anaesthetic machines & monitors

Model: 8607300

MHRA reference: 2021/012/021/487/012

GE Vingmed Ultrasound: Vscan Extend

73091

Ultrasound, imaging

MHRA reference: 2021/012/014/701/059

GE Healthcare 34122: Anaesthesia System

GEHC Ref # 34122

Anaesthetic machines & monitors

Model: Carestation 750 - Carestation 750c

MHRA reference: 2021/012/020/291/002

Hillrom: Liko M220 & Liko M230

FA 2021-010-002-LUL-001

Hoists and slings

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

MHRA reference: 2021/012/022/487/002

Intelerad: IntelePACS

15 December 2021

Picture archiving and communication system (PACS)

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

MHRA reference: 2021/012/015/601/006

Medtronic: HeartWare™ Ventricular Assist Device (HVAD™) System

December 2021

Implantable ventricular assist devices

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

MHRA reference: 2021/012/021/420/001

Medtronic: NIM Trivantage EMG Endotracheal tube

FA1218

Airway devices

Model: 8229705, 8229706, 8229707, 8229708, 8229709, 8229735, 8229736, 8229737, 8229738, 8229739

MHRA reference: 2021/012/022/487/003

NuVasive: MAGEC System

13 December 2021

Spinal implants

MHRA reference: 2021/012/014/601/504

Olympus: TJF-Q170V &TJF-Q190V & TJF-Q290

December 2021

Endoscopes, flexible

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

MHRA reference: 2021/012/021/487/013

Oserf: Reusable instruments SERF

23 November 2021

Orthopaedic surgical instruments - insertion/extraction tool

MHRA reference: 2021/012/022/487/006

Permobil: Tilite

FSCA Ref: CAPA10090

Wheelchairs, manual

Model: ZRA, Areo Z

MHRA reference: 2021/012/020/601/500

PerkinElmer: DELFIA Xpress hAFP kit

17 December 2021

IVDs, clinical chemistry

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

MHRA reference: 2021/012/017/701/016

Philips: Philips Allura Xper systems

December 2021

X Ray, fluoroscopy systems

MHRA reference: 2021/012/022/487/007

Siemens Healthcare: Atellica CH β2‑Microglobulin

December 2021

IVDs, clinical chemistry

Model: SMN 11097635

MHRA reference: 2021/012/003/601/003

Siemens Healthineers: Atellica CH and ADVIA Urinary/Cerebrospinal Fluid

September 2021

IVDs, clinical chemistry

MHRA reference: 2021/010/001/601/506

Fritz Stephan: Sophie

December 2021

Lung ventilators

MHRA reference: 2021/012/022/487/004

Theradiag SA: I-Tracker Infliximab

20 July 2021

IVDs, clinical chemistry

MHRA reference: 2021/009/021/579/002

Xstrahl: Concerto 2.x User Interface Software

26 April 2021

Radiotherapy

Model: X80, X100, X150, X200, X300

MHRA reference: 2021/004/022/701/046

Updates to this page

Published 24 December 2021