Field Safety Notices: 11 to 15 January 2021
List of field safety notices (FSNs) from medical device manufacturers from 11 January to 15 January 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.
Beckman Coulter: Access SARS-CoV-2 IgG Quality Control
06 January 2021
IVDs, SARS-CoV-2 antibody immunoassay
Model: Not applicable
MHRA reference: 2021/001/008/601/005
Bien-Air Surgery: Foot Pedals
17 December 2020
Surgical power tools
Model: 1600407 / 1600517 / 1600686
MHRA reference: 2021/001/008/601/003
DNAnudge: CovidNudge DnaCartridge
22 December 2020
IVDs, SARS-CoV-2 PCR test
Model: MX-0001
MHRA reference: 2020/012/021/601/003
DNAnudge: CovidNudge DnaCartridge
04 January 2021
IVDs, SARS-CoV-2 PCR test
Model: MK-0001
MHRA reference: 2021/001/004/601/002
Draeger Medical Systems: Infinity Acute Care System (M540)
December 2020
Monitors, patient
MHRA reference: 2021/001/008/701/022
GE Medical Systems: Revolution Apex, Revolution CT
08 January 2021
Computed tomography
MHRA reference: 2021/001/011/487/001
Helena BioSciences: APTT Si L Minus / APTT (SILICA)
21 October 2020
Coagulation
Model: 5558SLQ, 5559SLQ, 5560SLQ, 5562SLQ, OQLS065502, QLS265502, OQLS493502, OQLS955502
MHRA reference: 2020/011/011/487/013
Leonhard Lang: Schiller Defibrillation Electrode
14 January 2021
Defibrillators, non Implantable
Model: 2.155061 FRED EASYPORT
MHRA reference: 2021/001/014/701/007
Olympus KeyMed: See Excel “QIL 153-014_List of affected products”
15 January 2021
See Excel “QIL 153-014_List of affected products”
MHRA reference: 2021/001/008/487/011
Olympus Medical Systems: GASTROINTESTINAL VIDEOSCOPE / COLONOVIDEOSCOPE
January 2021
Endoscopes, flexible
Model: GIF-EZ1500, CF-EZ1500DL, CF-EZ1500DI
MHRA reference: 2021/001/012/291/001
Siemens Healthcare Diagnostics: Atellica IM 1300/1600 and CH 930 Analyzers
December 2020
IVDs, clinical chemistry
MHRA reference: 2020/012/009/601/007
Solutions for tomorrow: M1 mobile x-ray
14 January 2021
X Ray, Mobiles
MHRA reference: 2021/001/014/701/016