Field Safety Notice: 13 to 17 May 2019

List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 May 2019


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

Becton Dickinson: Alaris™ Pump Module 8100 and assemblies

17 May 2019

Infusion systems

Alaris™ Pump Module 8100 and assemblies

MHRA reference: 2019/005/015/291/008


24 April 2019

Optical, ophthalmic instruments and equipment

MHRA reference: 2019/004/029/487/017

Change Healthcare: Horizon/McKesson Cardiology Hemo

22 March 2019

Monitors, patient

Horizon Cardiology Hemo 12.2,

MHRA reference: 2019/005/014/291/005

Ethicon Endo-Surgery LLC

ENSEAL X1 tissue sealer curved jaw

Surgical, diathermy

MHRA reference: 2019/005/013/701/010

Fresenius: Orchestra Base Intensive and Orchestra Base Primea

13 May 2019

Infusion systems

Z081230 and Z081330

MHRA reference: 2019/005/001/291/002

Heinrich Medical

16 May 2019

Surgical, diathermy

MHRA reference: 2019/005/013/206/001

Maquet - Getinge QUADROX-i Neonatal Microporous Membrane Oxygenator

10 May 2019

Infusion and transfusion, heart lung circuits

MHRA reference: 2019/005/013/487/004

Medline Industries: Canister for large fluid volume collection

15 May 2019

Surgical equipment, miscellaneous

MHRA reference: 2019/005/015/487/007

Medtronic: Astra™, Azure™, Percepta™, Serena™, Solara™

May 2019

Implants, active, pacemakers

Model: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01 W3SR01, X2DR01, X3DR01, X2SR01, X3SR01, W1TR01, W1TR04, W4TR01, W4TR04, W1TR02, W1TR05, W4TR02, W4TR05, W1TR03, W1TR06, W4TR03, W4TR06

MHRA reference: 2019/005/013/487/005


May 2019

Endoscopes, flexible

TJF-Q190V and TJF-Q290V

MHRA reference: 2019/005/013/487/001

Pennine Healthcare: Brand

8 May 2019

Naso gastric feeding tube

Feeding Tubes, Levins Tubes, Neleton Catheters, Rectal Catheter, Ryles Tubes, Stomach Tubes, Suction Catheters, Medical Packs - Multiple,

MHRA reference: 2019/005/008/601/004

Pfizer: ThermaCare Lower Back and Hip Heatwraps

13 May 2019

Heating, patient, electrical pads and blankets

MHRA reference: 2019/005/010/291/006

Randox Laboratories: Pancreatic Amylase

1 May 2019

IVDs, clinical chemistry

Model: AY3855

MHRA reference: 2019/005/009/601/009

Siemens: IVDs, Clinical Chemistry

May 2019

Atellica CH analyzer creatine kinase

MHRA reference: 2019/005/015/291/006

Siemens: ADVIA

May 2019

IVDs, clinical chemistry

MHRA reference: 2019/005/013/601/004

Published 20 May 2019