Field Safety Notice: 30 September to 04 October

List of field safety notices (FSNs) from medical device manufacturers from 30 September to 04 October


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.


20 September 2019

IVDs, self / home testing

MHRA reference: 2019/009/013/228/013

Baxter: TherMax Blood Warmer Unit, ROW

October 2019

Blood/fluid warming systems

MHRA reference: 2019/010/003/228/001

Brainlab: Patient Data Manager (PDM)


Infusion systems

Please refer to “8 Comments” for model numbers

MHRA reference: 2019/009/030/701/006

Fast Track Diagnostics

September 2019

IVDs, viral microbiology

MHRA reference: 2019/009/027/487/018

Medoderm: LQD

30 September 2019

Basic dressings, absorbents, swabs, procedure packs

PZN-13833368; PZN-13833380; PZN-13833397 (only in Germany)

MHRA reference: 2019/010/001/601/003

Medtronic: Various

October 2019

Implants, active, defibrillators

Model: Various (please see FSN)

MHRA reference: 2019/010/003/487/013

Philips: V680 Ventilators

22 August 2019

Lung ventilators

V680 Ventilators

MHRA reference: 2019/009/023/487/038

Randox: Liquid Cardiac Controls

01 October 2019

IVDs, clinical chemistry

CQ5051, CQ5052, CQ5053

MHRA reference: 2019/010/002/601/002

Roche: Cardiac Pipettes

September 2019

IVDs, clinical chemistry

MHRA reference: 2019/010/001/701/026

Siemens: Atellica CH 930 Analyzer

September 2019

IVDs, clinical chemistry

Atellica CH 930 Analyzer

MHRA reference: 2019/009/026/601/003

Siemens: Atellica UAS 800 Analyzer

September 2019

IVDs, clinical chemistry

MHRA reference: 2019/009/030/601/005

Teleflex: EZ-IO 15MM needle + stabilizer BX/5 (EE)

03 October 2019

Injection devices

MHRA reference: 2019/010/003/487/012

Terumo: Terumo Hypodermic NEOLUS Needle

September 2019

Injection devices

Terumo Hypodermic NEOLUS Needle

MHRA reference: 2019/009/027/487/024

Vygon: V-Green Narrow Bore+Clamp IV Extension Line

03 October 2019

Infusion & transfusion, administration sets

6222.051, 6222.071, 6222.151, 6222.201

MHRA reference: 2019/010/003/601/003

Published 7 October 2019