Field Safety Notices: 5 to 9 September 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 September 2022

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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

CareDx: QTYPE 11

01 September 2022

IVDs, Immunology

MHRA reference: 2022/009/005/599/010

GE Healthcare: Aisys CS2, Avance CS2, Avance CS2 Pro

Ref 34129

Anaesthetic Machines & Monitors

MHRA reference: 2022/009/005/599/011

Getinge: 701069073, 701069076, 701069083 HLS Set Advanced 5.0, HLS Set Advanced 7.0

12 August 2022

Infusion & Transfusion, Heart Lung Circuits

MHRA reference: 2022/007/026/596/004

This is an update to the FSN first published in July 2022. The same products and lots are affected, which were already reported in the previous version of the FSN 656504. No additional or new actions for customers were added.

Getinge: Heater Unit HU 35

Ref 598097

Blood/Fluid Warming Systems

Model: 70103.5259; 70104.9090; 70107.2162; 70107.2163

MHRA reference: 2022/009/005/596/001

30 August 2022

Monitors, Patient

Model: 826820

MHRA reference: 2022/006/028/613/008

Philips: BiPAP A30 Ventilator (Respironics, Inc.) BiPAP A40

08 September 2022

Lung Ventilators

MHRA reference: 2022/008/005/596/008

This FSN only affects 40 devices. Please check if you have a device with a serial number which appears on the list within the FSN and follow the actions to be taken. No action is needed if your device serial number is not on the list.

Siemens: N Antiserum to Human IgG

August 2022

IVDs, Clinical Chemistry

MHRA reference: 2022/009/005/596/002

Updates to this page

Published 12 September 2022