Field Safety Notices: 4 to 8 July 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 July 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

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View . FSNs before this date are on the

CU Medical: Defibrillator (AED)

09 June 2022

Defibrillators, Non Implantable

Model: CU-SP1

MHRA reference:

Dentsply Sirona: Calibra Esthetic Resin Cement

08 June 2022

Dental Materials

MHRA reference:

Depuy: ATTUNE鈩� Measured Sizing & Rotation Guide Instrument

29 June 2022

Orthopaedic Surgical instruments

Model: 254400525

MHRA reference:

GE: Carestation 750 - Carestation 750c

Ref 34125

Anaesthetic Machines & Monitors

MHRA reference:

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:

GE: Centricity Universal Viewer Zero Footprint client

Ref 85464

Picture Archiving And Communication System (PACS)

MHRA reference:

HeartWare: Ventricular Assist System

June 2022

Implantable Ventricular Assist Devices

Model: 1650DE

MHRA reference:

23 May 2022

Joint Prosthesis, Knee

MHRA reference:

Mallinckrodt: INOmax DSIR

22 June 2022

Nitric Oxide Delivery System

MHRA reference:

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

17 June 2022

IVDs, Clinical Chemistry

MHRA reference:

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

15 December 2021

Endoscopes, Flexible

MHRA reference:

Schiller: DEFIGARD Touch-7

June 2022

Defibrillators, Non Implantable

MHRA reference:

ThermoFisher Scientific: Remel

14 March 2022

IVDs, Bacteriology

Model: R4601503

MHRA reference:

Updates to this page

Published 12 July 2022