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Field Safety Notices: 27 June to 1 July 2022

Medicines Healthcare Products Regulatory Agency

July 4
12:05 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: Hemoglobin A1c

09 June 2022

IVDs, Haematology

MHRA reference: 2022/006/013/701/032

GE: Centricity Universal Viewer Zero Footprint client

85465

Picture Archiving And Communication System (PACS)

MHRA reference: 2022/006/029/599/001

Hamilton Medical: 160021 HAMILTON-C6

24 June 2022

Ventilator

MHRA reference: 2022/006/015/611/001

22 June 2022

Monitors, Patient

Model: 826820

MHRA reference:2022/006/028/613/008

Kimal: Procedure Packs

23 May 2022

Basic Dressings, Absorbents, Swabs, Procedure Packs

Model:K20253,K2386/P1,K26254,K34027/P1,K38026,K46064/P1,K48787,K53899/P1,K54146/P1/PSP,K56673,K66150/P1,QA-K3372

MHRA reference: 2022/005/023/601/001

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

June 2022

Implants, Active, Defibrillators

Model: Cobalt XT VR: DVPA2D1, DVPA2D4 Cobalt XT DR: DDPA2D1, DDPA2D4 Cobalt XT HF: DTPA2D4, DTPA2D1 Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1 Cobalt VR: DVPB3D1, DVPB3D4 Cobalt DR: DDPB3D1, DDPB3D4 Cobalt HF: DTPB2D4, DTPB2D1 Cobalt HF Quad: DTPB2QQ, DTPB2Q1 Crome VR: DVPC3D1, DVPC3D4 Crome DR: DDPC3D1, DDPC3D4 Crome HF: DTPC2D4, DTPC2D1 Crome HF Quad: DTPC2QQ, DTPC2Q1 Cobalt XT HF Quad: DTPA2D1G, DTPA2QQ

MHRA reference: 2022/006/024/595/005

Nuvasive: Simplify Artificial Cervical Disc

13 June 2022

Spinal Implants

MHRA reference: 2022/006/020/601/010

Siemens: Artis Zeego

May 2022

X Ray, Fluoroscopy Systems

MHRA reference: 2022/005/024/601/503

Stryker: 1688 Camera Control Unit (CCU)

May 2022

Endoscopes, Televisual Systems

MHRA reference: 2022/002/022/291/001

Published 4 July 2022

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