Field Safety Notice - 19 November to 23 November 2018

List of field safety notices (FSNs) from medical device manufacturers from 19 November to 23 November


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


21 November 2018

IVDs, clinical chemistry

MHRA reference: 2018/011/022/487/015

Abbott: Alinity hq Analyzer Alinity hs Slide Maker Stainer Module

26 October 2018

IVDs, haematology

MHRA reference: 2018/010/016/487/012


19 November 2018

Surgical instruments, articulated holding

Model: 5193-06001-010

MHRA reference: 2018/011/019/291/014

Biohit: Lactose intolerance quick test

14 November 2018

IVDs, clinical chemistry

MHRA reference: 2018/011/016/291/005

GE: Giraffe Omnibed

FMI 32063

Infant incubators

MHRA reference: 2018/011/012/291/001

Getinge: Fibrocleaner


Cssd wash/clean/drying equipment

MHRA reference: 2018/011/021/487/018

Philips: Efficia 3/5 ECG Trunk Cable, AAMI/IEC

November 2018

Defibrillators, non-implantable

Model: 989803160641

MHRA reference: 2018/011/021/487/019

Philips: CombiDiagnost

16 October 2018

X Ray, fluoroscopy systems

Model: 709030

MHRA reference: 2018/011/019/291/001

Philips: HeartStart MRx Lithium Ion Module (Rechargeable)

November 2018

Defibrillators, non-implantable


MHRA reference: 2018/010/031/487/020

VascoMed: TC-115 Balloon

November 2018

Pacemakers, external

MHRA reference: 2018/011/019/701/005

Published 26 November 2018