Field Safety Notice: 02 to 06 December 2019

List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 December 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 Deutschland: Durapore™ Advanced Surgical Tape

27 November 2019

Bandages and tapes

MHRA reference: 2019/012/003/701/013

Abbott Medical: HeartMate 3™ Left Ventricular Assist System

02 December 2019

Implantable ventricular assist devices

Model: MPU: 107758, HM3 LVAS Kit: 106524INT, 106524

MHRA reference: 2019/012/002/291/016

Abbott Medical UK: HeartMate 3™ Left Ventricular Assist System

02 December 2019

Ventricular – pump

Model: 106525, 106525INT / 106524, 106524INT LVAS HM3 KIT

MHRA reference: 2019/012/002/291/017

AMO (Johnson & Johnson): Healon GV PRO

05 December 2019

Implants, non active, intraocular

MHRA reference: 2019/011/029/701/024

BioMérieux: VIDAS VARICEL. ZOSTER IGG 60 T

November 2019

IVDs, viral microbiology

MHRA reference: 2019/012/005/291/002

Convatec: FLUTED SILICONE ROUND DRAINS CH15 & CH1

29 November 2019

Wound drains

MHRA reference: 2019/011/027/291/014

Dexcom: Dexcom G6 iOS CGM Ap

02 December 2019

Continuous glucose monitoring systems (CGMS)

Model: SW11585, SW11586

MHRA reference: 2019/011/027/291/003

DXC Technology: i.Laboratory (Apex) AKI

20 November 2019

IVDs, clinical chemistry

MHRA reference: 2019/011/029/291/008

Edwards Life Sciences: Quickdraw - Peripheral venous access cannula

FCA152

Vascular cannula and catheters

Model: QD22, QD25

MHRA reference: 2019/012/004/291/005

Insignia Medical Systems: Insignia Insight PACS - Patient Explorer 2

21 November 2019

Picture archiving and communication system (PACS)

MHRA reference: 2019/012/002/291/005

Medline Industries: CHARGER BASE, UK PLUG

12 November 2019

Surgical equipment, miscellaneous

MHRA reference: 2019/012/003/291/001

Microvention: Detachable Azur Peripheral Coil System

FCA201903

Detachable azur peripheral coil system

MHRA reference: 2019/012/002/291/013

Microvention: MicroPlex and HydroCoil Embolic System

FCA201904

Embolisation coils

MHRA reference: 2019/012/005/291/001

NAL VON MINDEN: NADAL® hCG Pregnancy Test

29 December 2019

IVDs, extra laboratory testing

MHRA reference: 2019/012/002/701/044

ResMed: Stellar 100/ Stellar 150

05 December 2019

Lung ventilators

Model: 100, 150

MHRA reference: 2019/012/005/228/019

Siemens Healthcare: Atellica CH 930 Analyzer

November 2019

IVDs, clinical chemistry

MHRA reference: 2019/011/029/601/007

SLE: SLE6000 Infant Ventilator

28 November 2019

Lung ventilators

MHRA reference: 2019/011/029/291/004

Stryker Trauma: Delta Strike Plate IMN Instruments

06 December 2019

Osteosynthesis, nails intramedullary

MHRA reference: 2019/012/004/701/033

Van Oostveen Medical: Romed IV Catheters With Injection Por

25 November 2019

Vascular cannula and catheters

Model: IVCATH-(size), Romed IV Catheters With Injection Port

MHRA reference: 2019/012/002/291/004

ViewRay: Stereotacticradiotherapy/MRI System

3011233554-11-18-2019-003-C

Magnetic resonance, equipment & accessories

Model: MRIdian Linac System

MHRA reference: 2019/012/004/701/006

VISAMED (Gettinge): Sensation Plus 7.5Fr 40cc

29 May 2019

Cardiac assist pumps

Model: 0684-00-5658-01

MHRA reference: 2019/005/030/487/007

Wallac Oy: GSP Neonatal IRT kit

28 November 2019

IVD, genetic testing

Model: 3306-0010

MHRA reference: 2019/011/027/291/019

Updates to this page

Published 9 December 2019