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Field Safety Notices: 4 to 8 July 2022

Medicines Healthcare Products Regulatory Agency

July 12
11:28 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

CU Medical: Defibrillator (AED)

09 June 2022

Defibrillators, Non Implantable

Model: CU-SP1

MHRA reference: 2021/011/001/586/001

Dentsply Sirona: Calibra Esthetic Resin Cement

08 June 2022

Dental Materials

MHRA reference: 2022/007/005/701/125

Depuy: ATTUNE Measured Sizing & Rotation Guide Instrument

29 June 2022

Orthopaedic Surgical instruments

Model: 254400525

MHRA reference: 2022/006/030/613/005

GE: Carestation 750 - Carestation 750c

Ref 34125

Anaesthetic Machines & Monitors

MHRA reference: 2022/007/005/613/005

GE: Centricity PACS System

Ref 85463

Picture Archiving And Communication System (PACS)

Model: Software version number: Centricity PACS 7.0 SP0.0.4.7

MHRA reference: 2022/007/001/599/002

GE: Centricity Universal Viewer Zero Footprint client

Ref 85464

Picture Archiving And Communication System (PACS)

MHRA reference: 2022/006/028/599/004

HeartWare: Ventricular Assist System

June 2022

Implantable Ventricular Assist Devices

Model: 1650DE

MHRA reference: 2022/006/030/613/004

23 May 2022

Joint Prosthesis, Knee

MHRA reference: 2022/005/023/701/011

Mallinckrodt: INOmax DSIR

22 June 2022

Nitric Oxide Delivery System

MHRA reference: 2022/006/029/701/128

NAL VON MINDEN: Drug-Screen 7-ACL 200 Test

17 June 2022

IVDs, Clinical Chemistry

MHRA reference: 2022/006/030/701/055

Olympus: TJF-Q170V &TJF-Q190V & TJF-Q290

15 December 2021

Endoscopes, Flexible

MHRA reference: 2022/005/023/613/004

Schiller: DEFIGARD Touch-7

June 2022

Defibrillators, Non Implantable

MHRA reference: 2022/007/001/599/009

ThermoFisher Scientific: Remel

14 March 2022

IVDs, Bacteriology

Model: R4601503

MHRA reference: 2022/003/009/601/501

Published 12 July 2022

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