Field Safety Notices: 3 to 7 January 2022

Source: MHRA / Gov.uk

List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 January 2022

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 Molecular: Alinity m system

06 December 2021

IVDs, SARS-CoV-2 PCR Test

MHRA reference: 2021/012/008/701/052

bioMérieux: ID 32 C

07 January 2022

IVDs, bacteriology

MHRA reference: 2022/001/006/291/004

CooperSurgical: Milex Gellhorn

14 September 2021

Implants, non active, implantable incontinence and prolapse devices

Model: MXKPGSS2-1/4; MXPGSS2-1/4; MXPGSS2-3/4

MHRA reference: 2021/009/020/601/001

CooperVision : Hy-Care; All in one light; Refine one step; comfortvue; comfort drops; preservative free saline

REC030

Contact lenses, care products

Model: CLC005; CLC001; CLC003; CLC013; CLC009; CLC014

MHRA reference: 2021/012/021/601/500

Dedalus Medchart: Med Chart

02 November 2021

Software as a medical device (SaMD)

Model: v8.3.1.3.7.8, v10.1, v11, v12

MHRA reference: 2021/012/021/601/002

GE Vingmed Ultrasound: Vscan Extend

GEHC 73091

Ultrasound, imaging

MHRA reference: 2022/001/006/291/003

Imtmedical: Diagnostic Package Pulse Oxymetry/Capnography

23 December 2021

Lung ventilators

Model: 301.113.000; 301.114.000

MHRA reference: 2021/012/023/701/051

Intuitive Surgical: Reducer ,IS4000,12-8MM, Disposable

ISIFA2021-08-R

Surgical instruments, minimal access

Model: 470381-11

MHRA reference: 2022/001/006/291/002

Medtronic: Percept PC BrainSense

January 2022

Implantable neuro stimulators

Model: B35200

MHRA reference: 2021/010/015/579/002

Philips Medical: Allura Xper, UNIQ and CV20 systems

December 2021

X Ray, fluoroscopy systems

Model: 722003, 722005, 722006, 722008, , 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722031, 722033, 722034, 722036, 722038, 722039

MHRA reference: 2021/011/026/487/019

SynCardia: TAH-t System

21 December 2021

Implantable ventricular assist devices

MHRA reference: 2021/012/023/601/001

Published 10 January 2022
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