Field Safety Notice - 24 to 28 July 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 July 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

Becton Dickinson: BD MultiTEST™ CD3/CD8/CD45/CD4

26 July 2017

IVDs, cytopathology & histopathology

MHRA reference: 2017/007/027/701/004

Boston Scientific: AdVance XP Needle Passers

AdVance XP Procedure Pack

July 2017

Implants, non active, implantable incontinence and prolapse devices

MHRA reference: 2017/007/027/291/004

DePuy: CORAIL® COXA VARA HIGH OFFSET STEM

July 2017

Joint prosthesis, hip

Model: 3L93709;L20314

MHRA reference: 2017/007/027/701/021

Elekta: MOSAIQ

June 2017

Radiotherapy

MHRA reference: 2017/006/029/701/040

FUJIFILM: Amulet S/ Amulet F/ Innovality

FFUID 20170629

Mammography

MHRA reference: 2017/007/025/291/004

Hitachi (Roche): cobas c 501 / cobas c 502

20 July 2017

IVDs, clinical chemistry

Model: 04745914001 / 05964067001

MHRA reference: 2017/007/024/291/027

Hitachi: 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

21 June 2017

IVDs, clinical chemistry

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

Jarvik Heart: Jarvik 2000 VAS, Adult VAD, Post-Auricular Cable

21 July 2017

Implantable ventricular assist devices

Model: JHI-001

MHRA reference: 2017/007/027/601/001

LivaNova: PLATINIUM

24 July 2017

Implants, active, defibrillators

Model: PLATINIUM VR 1210 PLATINIUM VR 1240 PLATINIUM DR 1510 PLATINIUM DR 1540 PLATINIUM CRT-D 1711 PLATINIUM CRT-D 1741 PLATINIUM 4LV CRT-D 1744 PLATINIUM SonR CRT-D 1811 PLATINIUM SonR CRT-D 1841 PLATINIUM 4LV SONR CRT-D 1844

MHRA reference: 2017/007/025/291/009

Mathys: Affinis CoCr head 43/15/2

25 July 2017

Joint prosthesis, shoulder

Model: 102.02.00.15.0

MHRA reference: 2017/007/025/701/004

Meditech Systems: Meditech Systems Ltd - Adult APL Valve

24 July 2017

Breathing system components

Model: AC22APL60

MHRA reference: 2017/007/024/601/005

Phadia AB ( ThermoFisher Scientific)

22 June 2017

IVDs, immunology

Model: Phadia 1000

MHRA reference: 2017/006/022/601/005

Physio-Control:LIFEPAK® 15 MONITOR/DEFIBRILLATOR

July 2017

Defibrillators, non implantable

MHRA reference: 2017/007/019/701/015

Prism

7 July 2017

Hoists and slings

Model: 320

MHRA reference: 2017/004/018/401/005

QIAGEN

10 July 2017

IVD, genetic testing

Model: ipsogen BCR-ABL1 Mbcr IS-MMR Kit, ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit, ipsogen BCR-ABL1 Mbcr RGQ RT-PCR Kit

MHRA reference: 2017/007/025/701/009

Roche: Accu-Chek® Insight

SB_RDC_2017_04

Infusion systems

MHRA reference: 2017/007/025/291/019

Teleflex: Percuvance Percutaneous Surgical System

20 July 2017

Surgical instruments, articulated holding

MHRA reference: 2017/007/024/291/025

Thermo Fisher Scientific: Thermo Scientific Remel Vibrio Cholerae Ogawa agglutinating serum R30165201

25 July 2017

IVDs, bacteriology

MHRA reference: 2017/007/026/601/005

Thermofisher Scientific: Thermo Scientific Remel E. coli Polyvalent and Monovalent Agglutinating Sera

25 July 2017

IVDs, bacteriology

Model: Various

MHRA reference: 2017/007/026/60 1/006

Updates to this page

Published 31 July 2017