Field Safety Notices: 14 to 18 February 2022

List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 February 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.

Abbott Molecular: Integrated Reaction Unit (IRU)

11 February 2022

IVDs, clinical chemistry

MHRA reference: 2022/002/015/701/023

Astraia: Software

10 February 2022

Ultrasound, imaging

MHRA reference: 2022/002/014/291/018

B.Braun Melsungen: INF.SP.LINE,TRANS,PVC,LL,250CM-EU

08 February 2022

Infusion & transfusion, administration sets

Model: Infusomat Space Line

MHRA reference: 2022/002/009/601/001

BioMérieux SA: VIDAS CMV IgM

11 FEB 2022

IVDs, viral microbiology

MHRA reference: 2022/002/014/291/004

Breas Medical: Ventilator Trolley

31 January 2022

Lung ventilators

Model: 007384

MHRA reference: 2022/001/027/601/503

Chromsystems Instruments & Chemicals: Analytical column, MassChrom Free Metanephrines

19 January 2022

IVDs, clinical chemistry

Model: 81100

MHRA reference: 2022/001/021/601/500

CooperVision: Hy-Care Multipurpose Contact Lens Care Solution

D6F-0502

Contact lenses & shells

Model: CLC005

MHRA reference: 2022/002/009/601/500

Corin Ltd: Trinity Acetabular Hip System

26 January 2022

Orthopaedic surgical instruments - measuring tools

Model: 921.109

MHRA reference: 2022/001/028/601/505

Drägerwerk: Evita V300; Evita V500; Babylog VN500

August 2021

Lung ventilators

MHRA reference: 2021/008/018/487/001

ETAC A/S: Molift

17 August 2021

Hoists and slings

MHRA reference: 2021/010/011/579/008

IBA: ProteusPLUS, ProteusONE

11 February 2022

Radiotherapy

Model: Proteus 235

MHRA reference: 2022/002/014/291/017

Nissha Medical Technologies: CLARAVUE

16 February 2022

Electrophysiology measurement

MHRA reference: 2022/002/007/487/001

Philips Medical Systems: Philips StentBoost Live used with Philips Allura a

02 February 2022

X Ray, Fluoroscopy Systems

Model: StentBoost Live: 459801781661

MHRA reference: 2022/002/007/487/009

Philips Ultrasound: Esophageal/Rectal Temperature Probes

February 2022

Patient temperature measurement

MHRA reference: 2022/002/014/291/002

Siemens Healthcare: Ysio10281013

14 February 2022

X Ray, general

MHRA reference: 2022/002/014/601/001

Siemens Healthcare Diagnostics: Atellica CH Lithium_2 (LITH_2) Lithium test system Atellica CH Enzymatic Hemoglobin A1c (A1c_E) Hemoglobin A1c test system Atellica CH Calcium_2 (CA_2) Calcium test system Atellica CH Fructosamine (Fruc) Glycosylated hemoglobin assa

February 2022/ACHC22-2.A.OUS

IVDs, clinical chemistry

Model: 11532401, 11097536, 11097644, 11097637

MHRA reference: 2022/002/014/601/500

Siemens Healthcare: ARTIS icono / pheno

February 2022/DE MF 000006122

X Ray, fluoroscopy systems

Model: 11327600, 11327700, 10849000

MHRA reference: 2022/002/014/601/006

Siemens Healthcare: Artis systems with syngo Application Software version VE20

February 2022/AX006/22/S

X Ray, fluoroscopy systems

MHRA reference: 2022/002/014/601/003

Siemens Medical Solutions: Acuson Juniper 11361954

VA10D/VA10E/VA10F

Ultrasound, imaging

MHRA reference: 2022/002/004/601/501

Stryker: DARCO Non-Locking Screw 2.7 x 26mm

February 2022

Osteosynthesis, bone screws

MHRA reference: 2022/002/014/291/003

Tandem Diabetes Care: t:slim X2 Insulin Pump

February 2022

Infusion systems

MHRA reference: 2022/002/009/701/176

Updates to this page

Published 22 February 2022