Field Safety Notice - 17 to 21 July 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 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

Alere: Alere HIV Combo

14 July 2017

IVDs, viral microbiology

MHRA reference: 2017/007/017/291/028

Exactech: 3.2mm Vix Bit

11 July 2017

Orthopaedic surgical instruments - insertion/extraction tools

MHRA reference: 2017/007/017/291/057

Hitachi High Technologies: Cobas 6000, Cobas 8000

11 July 2017

IVDs, clinical chemistry

Model: cobas 6000 system cobas c501 module, model number: 04745914001

cobas 8000 modular analyzer cobas c502 module, model number: 05964067001

Acessories/spare part: Ultrasonic Mixer Cover (USM cover 3), catalogue number 05400937001

MHRA reference: 2017/007/013/701/002

Immucor GTI Diagnostics: LIFECODES HLA-DPA1/B1 SSO Typing Kit

07 July 2018

IVDs, immunology

MHRA reference: 2017/007/017/291/026

Lombard Medical: Altura Endograft System

30 June 2017

Implants, non-active, endoprostheses for aortic aneurysms

Model: 01-AA-24-090

MHRA reference: 2017/007/003/291/035

Medtronic: Euphora Rapid Exchange Balloon Dilatation Catheter / Solarice Rapid Exchange Balloon

Dilatation Catheter

13 July 2017

Vascular cannula and catheters

Model: Various, see customer letter

MHRA reference: 2017/007/014/291/012

Ortho-Clinical: ORTHO BioVue System (Rh/K Cassette)

13 July 2017

IVDs, blood transfusion

MHRA reference: 2017/007/017/601/002

Össur: Rebound Foot-Up

July 2017

Orthoses

Model: RFU50001, RFU500011, RFU50002, RFU500021

MHRA reference: 2017/007/018/291/005

Shippert Medical Technologies: Tissu-Trans

12 June 2017

Surgical instruments, minimal access

Model: Tissu-Trans Filtron 100, Tissu-Trans Filtron 500, Tissu-Trans

MHRA reference: 2017/006/030/291/037

Smith and Nephew: ENACT SEPTAL STAPLER 3-PACK

7 June 2017

Staples and staple guns

MHRA reference: 2017/007/013/291/006

Terumo: Terumo OPS Valve

17 July 2017

Infusion & transfusion, connectors

Model: OPS valve sterile, OPS valve non-sterile

MHRA reference: 2017/007/017/701/022

Toshiba: Radrex-i DRAD-3000E/W8

17 July 2017

X ray, digital acquisition systems

Model: Radrex-i DRAD-3000E/W8

MHRA reference: 2017/007/018/291/010

Zimmer Biomet: Persona Partial Knee Guide Size 8

14 July 2017

Orthopaedic surgical instruments - measuring tools

MHRA reference: 2017/007/017/291/009

Published 24 July 2017