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

Updates to this page

Published 18 January 2021