Field Safety Notices: 1 to 5 November 2021

List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 November 2021

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: SCORE 6

29 October 2021

IVDs, immunology

MHRA reference: 2021/011/001/579/013

Getinge: Customized tubing sets

28 October 2021

Infusion & transfusion, heart lung circuits

MHRA reference: 2021/011/001/579/014

Intelerad: IntelePACS

01 November 2021

Picture archiving and communication system (PACS)

Model: Enhanced Viewer

MHRA reference: 2021/011/001/601/001

Matrix Diagnostics: GHB Urine Cassette Test

26 October 2021

IVDs, extra laboratory testing

Model: MD1700

MHRA reference: 2021/010/026/601/002

Moog: FreeGo Pump

26 October 2021

Feeding systems and tubes

Model: 5400

MHRA reference: 2021/011/002/579/009

Owens and Minor: Sterling Zero Nitrile Powder-Free Exam Glove

14 October 2021

Gloves, surgical & examination

MHRA reference: 2021/010/021/291/002

Pajunk: SPROTTE NRFit

25 October 2021

Injection devices

Model: 051163-29A

MHRA reference: 2021/010/025/601/500

Philips: Philips Allura Xper and Azurion systems

October 2021

X Ray, fluoroscopy systems

Model: 722001, 722002, 722003, 722005, 722006, 722008, 722010

MHRA reference: 2021/011/003/579/008

Siemens Healthineers: ARTIS icono / pheno

October 2021

X Ray, fluoroscopy systems

Model: Cardio/Angio System

MHRA reference: 2021/010/011/601/002

Trinity Biotech: Bartels ELISA Legionella Urinary Antigen

21 October 2021

IVDs, bacteriology

MHRA reference: 2021/011/003/579/011

Updates to this page

Published 8 November 2021