Field Safety Notice - 29 August to 1 September 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August to 1 September 2017

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.

Beckman Coulter

17 August 2017

IVDs, viral microbiology

Model: N/A

MHRA reference: 2017/008/017/601/011

Erbe: Pneumo-Cryoprobe; flexible

07 July 2017

Surgical, diathermy

Model: Pneumo-Cryoprobe; flexible 20402-032, 20402-037, 20402-040

MHRA reference: 2017/008/024/291/013

Hamilton: Hamilton Ventilators C2/C3's

07 August 2017

Lung ventilators

MHRA reference: 2017/008/030/701/012

Hitachi

1 June 2017

IVDs, clinical chemistry

Model: cobas c 311 analyzer, cobas c 501 module, cobas c 502 module, cobas c 701 module, cobas c 702 module, cobas 8000 ISE module 900, cobas 8000 ISE module 1800

MHRA reference: 2017/003/008/291/014

Hitachi: Cobas 8000 core unit

16 August 2017

IVDs, clinical chemistry

Model: 05641446001

MHRA reference: 2017/007/024/701/012

Hitachi

17 August 2017

IVDs, clinical chemistry

Model: the immunology modules: - MODULAR ANALYTICS <E170> (GMMI 03617505001) - MODULAR ANALYTICS EVO <E170> (GMMI 04998642001) - cobas e 601 module (GMMI 04745922001) - cobas e 602 module (GMMI 05990378001)

MHRA reference: 2017/006/026/701/001

Illumina: MiSeqDx Cystic Fibrosis 139-Variant Assay (2 Runs)

21 August 2017

IVD, genetic testing

Model: PN 15036580

MHRA reference: 2017/008/030/291/001

Jarvik Heart Inc: Reserve Battery/Charger

28 August 2017

Implantable ventricular assist devices

Model: JHI-303

MHRA reference: 2017/008/028/601/010

Philips: IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5

August 2017

Monitors, patient

Model: IntelliVue Multi Measurement Server M3001A, M3001AL, M3002A, M8102A, M8105A

MHRA reference: 2017/008/024/291/025

Sage Products: Oral Care products

24 August 2017

Oral swabs

MHRA reference: 2017/008/025/701/009

Siemens: Artis one

12 July 2017

X Ray, fluoroscopy systems

MHRA reference: 2017/008/025/601/004

Siemens: Artis zee biplane and Artis Q biplane

17 August 2017

X Ray, fluoroscopy systems

MHRA reference: 2017/008/024/601/007

Smiths Medical: Graseby™ 3300 Pump and Locking Accessories

24 August 2017

Infusion systems

Model: 0128-0025; 0128-0135; 0128-0136; and 0128-0451

MHRA reference: 2017/008/029/291/032

St. Jude Medical (Abbott): Pacemakers

28 August 2017

Implants, active, pacemakers

Model: PM1260, PM1240, PM1272, PM2260, PM2240, PM2272, PM3222, PM3242, PM3262, PM1272, PM2272, PM3542, PM3562, PM1210, PM2210, PM3210, PM1222, PM1224, PM1226, PM2216, PM2218, PM2220, PM2222, PM2224, PM2226

MHRA reference: 2017/008/029/291/019

St. Jude Medical (Abbott): Implantable Cardioverter Defibrillators - See FSN.

28 August 2017

Implants, active, defibrillators

Model: All model numbers of the affected devices

MHRA reference: 2017/008/029/291/020

The Binding Site: Human α-1-Antitrypsin Kit for use on SPAplus®

24 August 2017

IVDs, clinical chemistry

Model: NK034.S

MHRA reference: 2017/008/025/601/001

Thermofisher Scientific: Thermo Scientific Oxoid Antimicrobial Susceptibility Test disc MEL25 MECILLINAM

29 August 2017

IVDs, bacteriology

MHRA reference: 2017/008/030/601/001

Zimmer: Vanguard Open Box Femoral Component

30 August 2017

Joint prosthesis, knee

Model: Vanguard Open Box Femoral Component

MHRA reference: 2017/008/031/291/010

Zimmer: A.T. S® 2200TS and A.T.S® 4000TS

28 August 2017

Surgical equipment, tourniquets

MHRA reference: 2017/008/030/291/012

Published 4 September 2017