Field Safety Notices - 31 October - 4 November 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 31 October - 4 November 2016

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

Biomet UK: Rebalance Ankle Talar Culcus Guides

28 October 2016

Orthopaedic surgical instruments - measuring tools

MHRA reference: 2016/010/028/701/013

Cepheid: Xpert ®MRSA Blood culture assay

7 October 2016

IVDs, bacteriology

MHRA reference: 2016/010/028/299/010

CME Medical: CME Ambulatory Syringe pumps - T34, T60 and TPCA

FSN2016-004

Infusion systems

Model: T34 - 100-lOOSM, T60 -100-100PSLM, TPCA - 100-106PSLM, PMP000

MHRA reference: 2016/010/027/291/017

Corin: Trinity

31 October 2016

Joint prosthesis, hip

Model: 104.2800, 104.3200, 1043600, 104.4000, 104.2805, 104.3205, 104.3605, 104.4005, 104.2810, 104.3210, 104.3610, 104.4010, 104.3215, 104.3615, 104.4015, 321.01.425, 321.02.432, 321.03.436, 321.04.436, 321.05.436, 321.04.440, 321.05.440

MHRA reference: 2016/010/031/601/010

Elekta

FCA-EIAB-0004

Radiotherapy

Model: 715000 (Perfexion) 1016200 (Icon)

MHRA reference: 2016/004/005/701/011

Gambro: 115244: AK 98, 230V, Efficient 115248: AK 98,230V, Bio Version, 115250: AK 98, 230V, Self-Care 955403: AK 98, 230V Bio, v2

November 2016

Dialysis, haemodialysis

Model: 115244, 115248, 115250, 955403

MHRA reference: 2016/011/001/291/015

GE Medical: Innova x100

FMI 12254

X-ray, fluoroscopy systems

Model: Innova x100

MHRA reference: 2016/010/027/701/008

IMPAC Medical Systems: Monaco RTP System

October 2016

Radiotherapy planning and verification systems

MHRA reference: 2016/011/001/701/002

Leonhard Lang: Defibrillation electrode SCHILLER DF87C and DF56C

27 October 2016

Defibrillators, non-implantable

Model: DF87C, DF56C

MHRA reference: 2016/010/028/299/006

Orion: QuikRead go instrument sw version 7.1.10/iFOBT

25 October 2016

IVDs, clinical chemistry

MHRA reference: 2016/010/026/701/002

Philips: Brilliance iCT SP, Brilliance iCT, Brilliance 64, Brilliance 40, Brilliance16, Brilliance 16P, Brilliance 10, Brilliance 6, Brilliance Big Bore Oncology, Brilliance Big Bore Radiology, Ingenuity Core, Ingenuity Core128, Ingenuity CT

26 October 2016

Computed tomography

Model: please see FSN

MHRA reference: 2016/011/001/299/001

Schaerer Medical: schaerer® axis

21 September 2016

Operating table

Model: axis 400/500/600/700/800

MHRA reference: 2016/010/021/701/001

Solmedia: FORM020

NCN-100369

IVDs, cytopathology & histopathology

MHRA reference: 2016/010/031/701/003

Stryker: 2.3MM Tapered Router

RA2016-060

Surgical power tools

MHRA reference: 2016/007/011/291/020

Stryker: Cup Positioner / Impactor Handle Assembly

RA 2016-107 – UPDATES

Orthopaedic surgical instruments - impacting tools

Model: Cup Positioner / Impactor Handle Assembly 2101-0200

MHRA reference: 2016/008/025/291/021

Teleflex Medical: Mucosal Atomization Device (MAD)

28 October 2016

Drug delivery system

MHRA reference: 2016/010/028/291/014

Teleflex Medical: Mucosal Atomization Device (MAD) FlexiNozzle Laryngo-Tracheal MAD, MADgic Endotracheal MAD, MADett

28 October 2016 EIF-000100

Nebulizers

Model: As per FSN

MHRA reference: 2016/010/031/299/012

Trinity Biotech: Bio-Rad RPR 100/Bio-Rad RPR 500/Bio-Rad RPR Cards

21 October 2016

IVDs, bacteriology

MHRA reference: 2016/010/027/701/010

3M Health Care

31 October 2016

Surgical, diathermy

Model: 3M™ Universal Electrosurgical Pad, solid, uncorded

MHRA reference: 2016/011/003/701/008

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