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 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
Tridentify AB: QTA Tracer 2.0
1st September 2018
MHRA reference: 31872430