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
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FSNs before this date are on the
Abbott: ID NOW COVID-19 24 Test Kit
27 October 2021
IVDs, SARS-CoV-2 PCR test
Model: 191-000
MHRA reference:
BBraun: NEXADIA monitor Set, monitor 2 Se
11 November 2021
Clinical patient record system
MHRA reference:
Bio-Rad: ID-Antigen Profile II
19 July 2021
IVDs, blood transfusion
Model: 50380
MHRA reference:
Chalice: ParaTherm Heater Cooler
FSN: 20211111P
Blood/fluid warming systems
MHRA reference:
Dedalus: Medchart
02 November 2021
Software as a medical device (SaMD)
MHRA reference:
DiaMex: QConnect HEPR
17 November 2021
IVDs, viral microbiology
MHRA reference:
GE Healthcare: Giraffe Range
FMI32079
Infant Incubators
MHRA reference:
Getinge: Cardiosave Intra-Aortic Balloon Pumps
16 November 2021
Cardiac assist pumps
Model: 0998-XX-0800-XX
MHRA reference:
Johnson & Johnson: Catalys庐 and iDesign庐
22 November 2021
Ophthalmic Laser System & Ophthalmic Refractometer
Model: Catalys: Catalys I, 0160-6010, iDesign: 0110-0001, 0110-3442
MHRA reference:
Medtronic: Recharger Kit - Wireless Model WR9220 and WR9200used with ACTIVA RC, InterStim Micro, RestoreUltra & RestoreSensor
November 2021
Implantable neuro stimulators
MHRA reference:
Randox: Cholesterol
18 October 2021
IVDs, clinical chemistry
Model: CH200
MHRA reference:
Rober:RM15 Apnoea Monitor
19 November 2021
Lung function/blood gas measurement
MHRA reference:
Siemens Healthineers:ACUSON Sequoia
VA25AVA25B
Ultrasound, imaging
Model: 11148775
MHRA reference:
Sunrise Medical:Quickie
November 2021
Wheelchairs, powered
Model: Q500M
MHRA reference:
Thermofisher Scientific: Campylobacter Test
September 2018
IVDs, bacteriology
Model: DR0155M
MHRA reference:
Tridentify AB: QTA Tracer 2.0
1st September 2018
MHRA reference: 31872430