Field Safety Notice: 01 to 05 April 2019

List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 April 2019

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

3M: 3M™ Reston™ Self-Adhering Foam

2 April 2019

Pressure relief cushions MHRA reference: 2019/004/002/701/006

Abbott: BrandHM3™ Outflow Graft, HM3™ LVAS Kit

01 April 2019

Implantable ventricular assist devices 105581INT, 106524INT MHRA reference: 2019/004/001/291/012

Abbott: Alinity hq Analyzer

29 March 2019

IVDs, haematology

MHRA reference: 2019/004/002/487/027

Draeger: Infinity Acute Care System (M540)

March 2019

Monitors, patient

MHRA reference: 2019/004/002/291/006

Edwards Life Sciences: Vamp Optima

FCA 127 Storage & collection devices MHD8VLTW, MHD8VRL5 and VOPTIMAL

MHRA reference: 2019/004/001/291/002

Elekta: Elekta Unity

March 2019

Radiotherapy

MHRA reference: 2019/004/002/291/005

GE: Giraffe Bedded Warmers, Panda iRes Warmers

FMI 32067 Infant incubators Giraffe Bedded Warmers, Panda iRes Warmers

MHRA reference: 2019/004/001/291/006

GE: Aysis, Aisys CS2

FMI 34098

Anaesthetic machines & monitors

MHRA reference: 2019/004/002/291/004

Hoggi: CLEO

18 October 2018

Wheelchairs, manual 3279-0032 MHRA reference: 2019/004/001/291/011

Johnson & Johnson: ILS Proximate Circular Stapler

29 March 2019

Staples and staple guns MHRA reference: 2019/003/028/701/016

Maquet (Getinge): 720001B2, 720001B0, 720001F2, 720001F0, 710001B2,

02 April 2019

Operating table

MHRA reference: 2019/004/002/487/028

Medtronic: DRILL MINI-TREPHINATION 2.0mm

March 2019

Surgical power tools

Model: 1882900

MHRA reference: 2019/003/029/487/004

Medtronic

April 2019 Implants, active, stimulators, neuro A610 MHRA reference: 2019/004/002/291/002

Molnlycke Health Care: Mölnlycke® Detachable EndoRetrieval Pouch

01 April 2019

Surgical instruments, minimal access

Model: 899103-01

MHRA reference: 2019/003/029/487/008

PREVOR: DIPHOTERINE

18 March 2019

Detergents Model: MINI-DAP & MICRO-DAP

MHRA reference: 2019/003/028/601/002

PROCEPT BioRobotics: AQUABEAM Handpiece

12 March 2019

Therapy tissue ablation

Model: 320301

MHRA reference: 2019/003/007/701/012

Roche: BILD2 (Bilirubin direct Gen.2)

March 2019

IVDs, clinical chemistry MHRA reference: 2019/003/029/701/006

Zimmer: Foot and Ankle Inst. (Drill / Tap and Countersink)

27 March 2019

Various devices affected

MHRA reference: 2019/004/002/291/003

Published 8 April 2019