Field Safety Notice - 17 - 21 December 2018

List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 December 2018

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

Abbott: ARCHITECT Rubella IgM

18 December 2018

IVDs, viral microbiology

MHRA reference: 2018/012/019/487/013

Bayer: MAVIG® Portegra2 Overhead Counterpoise System

14 December 2018

X ray, ancillary equipment and accessories

MHRA reference: 2018/012/017/701/028

Beckman Coulter: UniCel DxI 600/800 Access Immunoassay Systems, UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems

Model number Catalogue number: DxI 800: 973100, A71456, A71457, A84545, A25288, A25285 DxI 600: A30260, A71460, A71461, A92060 DxC 660i: A64871 DxC 680i: A64903 DxC 860i: A64935 DxC 880i: A59102

18 December 2018

IVDs, clinical chemistry

MHRA reference: 2018/012/019/601/008

BIOMERIEUX: VITEK® 2 AST-N351 Test Kit

18 December 2018

IVDs, bacteriology

Model: 421257

MHRA reference: 2018/012/018/291/007

Biomet (Zimmer): Max VPC Instrument Tray & Screw Caddy

20 December 2018

Surgical devices, non-powered

MHRA reference: 2018/012/020/291/007

Cochlear: Baha 5 Sound Processor Tamper-proof battery door 3

20 December 2018

Implants, active, hearing

Model: P1129017

MHRA reference: 2018/012/020/601/003

Convatec (Medtronic): Medtronic MiniMed™ Mio™ Advance Infusion Set 2018121719

Infusion & transfusion, administration sets

MHRA reference: 2018/012/019/487/009

Flexicare: Laryseal Flexi Laryngeal Mask

20 December 2018

Airway devices

MHRA reference: 2018/012/014/487/008

Integra Lifesciences: MAYFIELD® Skull Clamps

14 December 2018

Surgical instruments, articulated holding

Model: A1059, A1108, A1114, A1117, A2000, A2114, A3059

MHRA reference: 2018/012/017/487/012

Medtronic: StealthAir™ Percutaneous Pin Adapter

December 2018

Surgical navigation system and accessories

Model: 9734752

MHRA reference: 2018/012/020/291/002

Nipro: SurdialTM X

20 December 2018

Dialysis, haemodialysis

MHRA reference: 2018/012/012/291/002

Richard Wolf: BRONCHOSKOP-TUBUS;

825200841,825200842,825201041,825201241,825201441 /

06 December 2018

Endoscopes, flexible

MHRA reference: 2018/010/008/228/002

Schiller: CARDIOVIT MS-2007; MS-2010; MS-2015

22 November 2018

ECG

MHRA reference: 2018/012/019/291/005

SCHULTE-ELEKTRONIK: SISS BABYCONTROL

14 December 2018

Monitors, patient

MHRA reference: 2018/012/017/291/008

Siemens: Dimension Vista 1500

December 2018

IVDs, clinical chemistry

MHRA reference: 2018/012/017/601/006

Smith & Nephew: JOURNEY DCF AP Femoral Cutting Block Size 3

13 December 2018

Orthopaedic surgical instruments - Insertion/extraction tools

MHRA reference: 2018/012/020/291/003

Sorin CRM: PLATINIUM ICDs and CRT-Ds

14 December 2018

Implants, active, defibrillators

MHRA reference: 2018/011/029/291/001

Stryker: Tritanium PL Spinal Cage

17 December 2018

Spinal implants

MHRA reference: 2018/012/017/487/013

Terumo: Spectra Optia Apheresis System

December 2018

Apheresis

Model: 61000

MHRA reference: 2018/012/010/291/005

Updates to this page

Published 24 December 2018