Field safety notices - 4 April to 8 April 2016

List of field safety notices (FSNs) from medical device manufacturers from 4 April to 8 April 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

Applied Medical Resources: CA090, Direct Drive® Clip Applier 3/BX

30 March 2016

Clip appliers

Model: CA090 and any associated kits including the CA090

MHRA reference: 2016/004/006/291/022

BIOMERIEUX: M.HINTON 2 SHEEP BLOOD 90 20PL

30 March 2016

IVDs, bacteriology

MHRA reference: 2016/003/031/292/005

Biomet: Biolox Delta Head, 36mm Std Neck, 12/14 Taper

29 March 2016

Joint prosthesis, hip

MHRA reference: 2016/004/005/701/012

Boston Scientific

4 April 2016

Implants, non-active, cardiac appendage, and septal defect occluders / plugs

Model: M635WS50200, M635WS50240, M635WS50270, M635WS50310, M635WS50350,

MHRA reference: 2016/003/029/292/014

Corinthian Surgical: SerenoCem Granules BCG050

18 March 2016

Implant materials, bone substitutes

MHRA reference: 2016/004/007/291/013

Elekta

FCA-EIAB-0004

Radiotherapy

Model: 715000 (Perfexion) 1016200 (Icon)

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

Fritz Stephan: Stephanie; 1007-61-500 & 1007-61-550 / 103561000

12 January 2016

Lung ventilators

Model: Stephanie

MHRA reference: 2016/002/022/291/002

GE Healthcare

FMI34076

Anaesthetic machines and monitors

Model: Aisys CS2

MHRA reference: 2016/003/030/292/009

Hamilton Medical

7 March 2016

Lung ventilators

Model: HAMILTON-G5 / S1

MHRA reference: 2016/003/010/292/024

Hitachi: Hitachi Aloka

4 April 2016

Ultrasound, Imaging

Model: ARIETTA 60, ARIETTA 70

MHRA reference: 2016/004/007/701/019

Intuitive Surgical

1 April 2016

Endoscopes, rigid

Model: da Vinci S/Si/Xi Surgical Systems

MHRA reference: 2016/004/004/701/010

Maquet: Extensionsansteckgerät zum OP-Tisch-Systems MAGNUS; 1180.19A0 / 1180.19A0

17 February 2016

Therapy, traction

MHRA reference: 2016/003/010/292/016

Medtronic

4 April 2016

Monitors, patient

Model: 2490C Medtronic CareLink Monitor (Patient Home

MHRA reference: 2016/004/004/291/001

Philips Medical Systems: EPIQ

23 March 2016

Ultrasound, Imaging

Model: EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W

MHRA reference: 2016/004/004/299/005

Siemens: Dimension / Dimension Vista / ADVIA Chemistry Systems

March 2016

IVDs, clinical chemistry

MHRA reference: 2016/004/001/601/011

Siemens: ADVIA Centaur CP 10309710

CI-16-03.A.OUS

IVDs, clinical chemistry

MHRA reference: 2016/004/005/601/003

Smith & Nephew: BHR Extraction Kit

28 March 2016

Surgical instruments, implant

MHRA reference: 2016/004/001/292/002

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