Field Safety Notices: 28 March to 1 April 2022

List of field safety notices (FSNs) from medical device manufacturers from 28 March to 1 April 2022.

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

The 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: TactiCath Contact Force Ablation Catheter, SE

24 March 2022

Therapy tissue ablation

Model: A-TCSE- DF; A-TCSE- DD

MHRA reference: 2022/003/029/291/001

Abbott: Alinity i Homocysteine Reagent Kit

24MAR2022

IVDs, clinical chemistry

MHRA reference: 2022/003/025/701/070

Baxter: Artiset HD DNL HC

23 March 2022

Dialysis, blood lines

MHRA reference: 2022/003/024/291/003

ConvaTec: Suction Catheters

TW1527576

Airway suction equipment

MHRA reference: 2022/003/029/291/002

Corin: MetaFix 579.1007

22 March 2022

Joint prosthesis, hip

MHRA reference: 2022/003/025/601/007

Getinge: Advanta V12 Covered Stent System

02 March 2022

Implants, non active, peripheral vascular stents

MHRA reference: 2022/003/011/291/002

Getinge: GETINGE CM320-SERIES

21 March 2022

Cssd wash/clean/drying equipment

Model: CM320-2 Chamber WD, CM320-2 Chamber WU, CM320-4

MHRA reference: 2022/003/024/291/005

Intuitive: SureForm 45, 45 Curved-Tip, 60

ISIFA2022-02-C

Staples and staple guns

Model: 480445, 480545, 480460

MHRA reference: 2022/003/030/701/034

Medtronic: Puritan Bennett 980 Ventilator System

March 2022

Lung ventilators

Model: ALL

MHRA reference: 2022/003/029/291/003

Philips: StentBoost Live used with Philips Azurion

02 February 2022

X Ray, fluoroscopy systems

Model: StentBoost Live: 459801781661 Phillips Azurion: 722079, 722136, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228

MHRA reference: 2022/002/007/487/010

Randox: Total Bile Acids

18 February 2022

IVDs, clinical chemistry

MHRA reference: 2022/003/004/601/501

Seegene: Allplex SARS-CoV-2 Variants II Assay

FSN-20220225-RV10305X

IVDs, SARS-CoV-2 PCR Test

Model: RV10305X, RV10306Y

MHRA reference: 2022/003/018/601/003

Sentinel Diagnostics: Copper, Clin Chem Control 1 & 2

23 March 2022

IVDs, clinical chemistry

MHRA reference: 2022/003/024/291/007

Siemens Medical Solutions: Symbia Intevo 6 and Intevo Bold

CAN 022-2022

SPECT-CT

Model: 10764803, 11007962

MHRA reference: 2022/003/016/601/500

Updates to this page

Published 4 April 2022