Field Safety Notices: 22 to 26 November 2021

List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 November 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: ID NOW COVID-19 24 Test Kit

27 October 2021

IVDs, SARS-CoV-2 PCR test

Model: 191-000

MHRA reference: 2021/011/008/601/501

BBraun: NEXADIA monitor Set, monitor 2 Se

11 November 2021

Clinical patient record system

MHRA reference: 2021/011/011/601/508

Bio-Rad: ID-Antigen Profile II

19 July 2021

IVDs, blood transfusion

Model: 50380

MHRA reference: 2021/011/017/601/500

Chalice: ParaTherm Heater Cooler

FSN: 20211111P

Blood/fluid warming systems

MHRA reference: 2021/011/023/601/501

Dedalus: Medchart

02 November 2021

Software as a medical device (SaMD)

MHRA reference: 2021/011/017/579/001

DiaMex: QConnect HEPR

17 November 2021

IVDs, viral microbiology

MHRA reference: 2021/011/018/579/022

GE Healthcare: Giraffe Range

FMI32079

Infant Incubators

MHRA reference: 2021/011/024/487/006

Getinge: Cardiosave Intra-Aortic Balloon Pumps

16 November 2021

Cardiac assist pumps

Model: 0998-XX-0800-XX

MHRA reference: 2021/011/018/579/021

Medtronic: Recharger Kit - Wireless Model WR9220 and WR9200used with ACTIVA RC, InterStim Micro, RestoreUltra & RestoreSensor

November 2021

Implantable neuro stimulators

MHRA reference:2021/011/022/291/001

Randox: Cholesterol

18 October 2021

IVDs, clinical chemistry

Model: CH200

MHRA reference: 2021/011/017/601/003

Rober:RM15 Apnoea Monitor

19 November 2021

Lung function/blood gas measurement

MHRA reference: 2021/011/025/487/010

Siemens Healthineers:ACUSON Sequoia

VA25AVA25B

Ultrasound, imaging

Model: 11148775

MHRA reference:2021/011/017/601/504

Sunrise Medical:Quickie

November 2021

Wheelchairs, powered

Model: Q500M

MHRA reference: 2021/011/004/601/501

Thermofisher Scientific: Campylobacter Test

September 2018

IVDs, bacteriology

Model: DR0155M

MHRA reference: 2021/011/004/601/502

Published 1 December 2021