Field Safety Notices - 27 April to 1 May 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 27 April to 1 May 2020

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: ARCHITECT iGentamicin Reagent Ki

24 April 2020

IVDs, clinical chemistry

MHRA reference: 2020/004/027/487/004

Becton Dickinson: BD BBL™ Gram Crystal Violet 250mL & Grain Stain Ki

30 April 2020

IVDs, bacteriology

MHRA reference: 2020/004/028/487/005

GE Healthcare: Carescape One

FMI 36145

Monitors, patient

MHRA reference: 2020/004/030/487/010

Merit Medical: SCOUT® Guide and SCOUT CHECK® Handpiece

Over label devices

Surgical navigation system and accessories

MHRA reference: 2020/004/024/487/004

Radiometer Medical: ABL80 FLEX/CO-OX

27 April 2020

IVDs, extra laboratory testing

Model: ABL80 FLEX (393-839) and ABL80 CO-OX (393-841)

MHRA reference: 2020/004/023/291/005

Schiller: MedilogAR

07 April 2020

ECG

MHRA reference: 2020/004/028/487/004

Siemens Healthcare: Artis icono

April 2020

X Ray, fluoroscopy systems

MHRA reference: 2020/004/028/601/002

Siemens Healthcare GmbH: Cios Spin & Cios Alpha

April 2020

X Ray, fluoroscopy systems

Model: VA20, VA30

MHRA reference: 2020/004/028/601/001

Smith & Nephew: R3 Acetabular Shells

22 April 2020

Joint prosthesis, hip

MHRA reference: 2020/004/027/487/001

SunTech Medical: SunTech, Oscar 2

16 April 2020

Monitors, blood pressure

Model: 250

MHRA reference: 2020/004/024/487/001

Zimmer Biomet: Polyethylene Implants

30 April 2020

Various Devices affected

MHRA reference: 2020/004/030/487/009

Updates to this page

Published 4 May 2020