Field Safety Notice - 19 to 23 February 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 February 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

Beckman Coulter: COULTER EPICS & FC 500™ Series Flow Cytometers

17 January 2018

IVDs, haematology

MHRA reference: 2018/001/019/601/003

Haemonetics: Bloodtrack Manager / Courier / Emerge

16 February 2018

Blood refrigerators

MHRA reference: 2018/002/019/291/010

Ion Beam Application Dosimetry: ProteusPLUS and proteusONE

16 February 2018

Radiotherapy

Model: Proteus 235

MHRA reference: 2018/002/016/291/013

IBL International

02 February 2018

IVDs, clinical chemistry

MHRA reference: 2018/002/002/000/012

Jiangsu Dynamic Medical Technology: DU893 Portable Dental Unit / DYNAMIC/Dynamic Medical

November 2017

Dental, laboratory equipment

MHRA reference: 2018/002/006/291/001

Mast Group Ltd: MPM-AUG32 Mast Uri Plates

16 February 2018

IVDs, bacteriology

MHRA reference: 2018/002/020/601/005

Medica: REXSYS 27H

11 December 2017

Dialysis, haemodialysis

MHRA reference: 2018/002/020/291/006

Roche Diagnostics GmbH: 03337111001

09 February 2018

IVDs, extra laboratory testing

Model: Cobas b 221 systems equipped with AutoQC module

MHRA reference: 2018/002/014/478/011

Smiths Medical: Medfusion® Model Series 3010, 3500, 4000

20 February 2018

Infusion systems

Model: 880.5725 Infusion Pump

MHRA reference: 2018/002/019/291/002

Southmedic: EtCO2 OxyMask

14 February 2018

Breathing system components

Model: OK-2125-8, OM-2125-14, OM-2125-8, OM-2325-8, OP-2125-8

MHRA reference: 2018/002/019/478/007

Stryker: Triathlon® Knee System 5mm & 10mm Tibial Augment

February 2018

Joint prosthesis, knee

MHRA reference: 2018/002/009/701/014

SynCardia Systems: Freedom Driver System

December 2017

Implantable ventricular assist devices

Model: 595000-001

MHRA reference: 2017/011/030/601/015

Updates to this page

Published 26 February 2018