Field Safety Notice - 15 to 19 May 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 15 May - 19 May 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: Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor; Refer to section 8

17 May 2017

IVDs, clinical chemistry

Model: Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor; Not applicable

MHRA reference: 2017/005/017/601/007

Biomet: T.E.S.S. Reverse Shoulder System

11 May 2017

Joint Prosthesis, Shoulder

MHRA reference: 2017/005/012/701/016

Covidien: Endo Peanut Auto Suture Blunt Dissector 5mm

12 May 2017

Surgical instruments, minimal access

Model: Endo Peanut Auto Suture Blunt Dissector 5mm

MHRA reference: 2017/005/015/291/011

Datex-Ohmeda: Carestation 620, Carestation 650, Carestation 650c

FMI 34082

Anaesthetic machines & monitors

MHRA reference: 2017/005/017/701/008

Medtronic: KYPHON® Directional Bone Filler

May 2017

Bone Cement and tools

MHRA reference: 2017/005/018/291/014

Medtronic: NavLock™ Tracker (part of below NavLock™ instrument sets and kits)

May 2017

Surgical navigation system

Model: 9734228, 9734259, 9734315, 9734489, 9734590, 9734682, 9734683, 9734734, 9734833, 9734837, 9734906, 9734907, 9734908, 9734914, 9735120

MHRA reference: 2017/005/018/291/001

Merck: Bioscot

12 May 2017

IVDs, blood transfusion

Model: Bioscot; Monoclonal Control Reagent

MHRA reference: 2017/004/021/601/002

Microgenics: Various Microgenics Application Sheets

16 May 2017

IVDs, clinical chemistry

Model: assay application sheets

MHRA reference: 2017/005/016/601/005

Philips: V60 Ventilator

20 April 2017

Lung Ventilators

MHRA reference: 2017/005/015/291/006

Roche: cobas® 6800 System / cobas® 8800 System

10 May 2017

IVDs, viral microbiology

Model: 05524245001 / 05412722001

MHRA reference: 2017/005/016/701/016

Sendal: 2-WAY EXT.LINE FOR PCA, BCV,ROT.L.LOCK

15 May 2017

Infusion & transfusion, administration sets

Model: PCA-01

MHRA reference: 2016/002/017/292/008

Siemens: RAPIDLab 348 Gas cartridge pack

May 2017

IVDs, Extra Laboratory Testing

MHRA reference: 2017/005/015/601/006

Siemens: N Protein Standard SL; N/T Protein Control SL

May 2017

IVDs, clinical chemistry

MHRA reference: 2017/005/016/701/014

Siemens: Dimension Vista PROT1CAL & PROT1 CON ( L & M & H)

May 2017

IVDs, clinical chemistry

MHRA reference: 2017/005/016/701/018

Vapotherm

23 March 2017

Humidifiers

Model: PF-UNIT Vapotherm Precision Flow

MHRA reference: 2017/004/003/701/015

Updates to this page

Published 22 May 2017