Field Safety Notices: 25 to 29 July 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 July 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

B. Braun: ENNOVATE IMPLANTS SY001TS

11 July 2022

Osteosynthesis, Bone Screws

MHRA reference: 2022/007/011/601/500

bioMérieux: VIDAS FT4

22 July 2022

IVDs, Viral Microbiology

MHRA reference: 2022/007/021/596/001

bioMérieux: VITEK 2 System

26 July 2022

IVDs, Bacteriology

MHRA reference: 2022/007/021/596/002

GCE: Combi Valve

22 July 2022

Regulators for gas cylinders

Model: 0718112, 0718139, 0718140, 0718113, 0718138

MHRA reference: 2022/007/028/291/006

GE Healthcare: SIGNA Premier

Ref 60986

Magnetic Resonance, Equipment & Accessories

MHRA reference: 2022/007/020/701/203

GE Healthcare: Centricity Universal Viewer

Ref 85465

Picture Archiving And Communication System (PACS)

MHRA reference: 2022/007/028/596/001

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

July 2022

Infusion & Transfusion, Heart Lung Circuits

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

INTCO: Quickie Q50R

11 July 2022

Wheelchairs, Powered

MHRA reference: 2022/007/026/596/001

Medtronic: HeartWare Ventricular Assist System

July 2022

Implantable Ventricular Assist Devices

Model: MCS1705PU, 1104

MHRA reference: 2022/005/012/611/003

Meridian Medical: Valon

08 July 2022

Ophthalmic, Laser

MHRA reference: 2022/007/020/596/011

Siemens: Atellica IM 1300 and IM 1600 Analyzers

April 2022

IVDs, Clinical Chemistry

Model: (SMN 11066001) & (SMN 11066000)

MHRA reference: 2022/004/021/601/501

ThermoFisher Scientific: vRapID NF PLUS System 20/K Remel

21 July 2022

IVDs, Bacteriology

MHRA reference: 2022/007/021/601/009

Ventinova Medical: Evone

31 May 2021

Lung Ventilators

Model: REF: 6000

MHRA reference: 2021/006/002/487/022

Updates to this page

Published 1 August 2022