Field Safety Notices: 25 to 29 April 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 April 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: Dragonfly Opstar Imaging Catheter

11 April 2022

Optical coherence tomography

Model: 1014651, 1014652

MHRA reference: 2022/004/009/701/007

Avanos Medical: CORTRAK 2 Enteral Access System

25 March 2022

Feeding systems and tubes

MHRA reference: 2022/004/011/601/505

Baxter Healthcare: EASYGRIP FLO-41 Precision MIS Delivery System

11 April 2022

Haemostatic agents

MHRA reference: 2022/004/019/291/003

Osatu, S Coop: REANIBEX300, REANIBEX500/BEXEN CARDIO/OSATU S.COOP

04 April 2022

Defibrillators, non implantable

MHRA reference: 2022/004/021/291/003

EBR Systems: WiSE CRT System

14 April 2022

Implants, active, intracardiac (leadless)

Model: WiSE CRT System

MHRA reference: 2022/004/014/701/095

EBR Systems: WiSE CRT Programmer

FSN 22-004

Implants, active, intracardiac (leadless)

Model: 5100

MHRA reference: 2022/004/015/701/004

Endo Tools Therapeutics: 1. TAPES; 2. endomina v2

21 March 2022

Sutures

MHRA reference: 2022/004/004/601/502

Medtronic: Cobalt XT, Cobalt, Crome Implantable Cardioverter/Defibrillator Systems

April 2022

Implants, active, cardiac resynchronisation therapy

Model: Cobalt XT VR: DVPA2D1, DVPA2D4 Cobalt VR: DVPB3D1, DVPB3D4 Cobalt XT DR: DDPA2D1, DDPA2D4 Cobalt DR: DDPB3D1, DDPB3D4 Cobalt XT HF: DTPA2D4, DTPA2D1 Cobalt HF: DTPB2D4, DTPB2D1 Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1 Cobalt HF Quad: DTPB2QQ, DTPB2Q1 Crome VR: DVPC3D1, DVPC3D4 Crome DR: DDPC3D1, DDPC3D4 Crome HF: DTPC2D4, DTPC2D1 Crome HF Quad: DTPC2QQ, DTPC2Q1

MHRA reference: 2022/004/021/291/002

Ortho Clinical Diagnostics: ORTHO Optix Reader ORTHO BioVue Cassettes

19 April 2022

IVDs, Blood Transfusion

Model: 6842223

MHRA reference: 2022/004/013/601/507

Philips: V60 Ventilator V60 PLUS, V680

21 April 2022

Lung ventilators

MHRA reference: 2022/003/021/291/006

Phoenix: Volumed set

26 April 2022

MHRA reference: 5331276

Radiometer: PICO50 Arterial Blood Sampler

FRM-02872

Storage & collection devices

MHRA reference: 2022/004/019/291/004

Randox: CK-MB Calibrator

25 March 2022

IVDs, clinical chemistry

MHRA reference: 2022/004/011/601/501

Siemens: ARTIS icono

April 2022

X Ray, fluoroscopy systems

MHRA reference: 2022/004/011/601/502

ThermoFisher: Phadia 200

FSN2022-02

IVDs, immunology

Model: 12-4300-00

MHRA reference: 2022/004/005/601/504

Water: Xevo TQ-S, TQD, TQ-S Micro and TQ-XS

1218959-10.08.2021-001-C

IVDs, clinical chemistry

Model: 186005453IVD, 186005833IVD, 186007833IVD, 186008453IVD

MHRA reference: 2022/004/013/601/506

Updates to this page

Published 3 May 2022