Field safety notices - 11 April to 15 April 2016

List of field safety notices (FSNs) from medical device manufacturers from 11 April to 15 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

Bausch + Lomb:1,5mm X 1,7mm Trapezoid Angled 6/Box

16 March 2016

Surgical instruments, non-articulated cutting

Model: E7599

MHRA reference: 2016/003/018/299/002

Draeger

March 2016

Anaesthetic machines & monitors>

Model: D-Vapor; D-Vapor 3000, Anesthesia Unit Vaporizers

MHRA reference: 2016/004/011/299/019

Europlaz Technologies: Tivatek

April 2016

Infusion and transfusion, administration

Model: Tivatek intravenous (IV) anaesthesia sets

MHRA reference: 2016/004/012/299/006

Leica Biosystems: Novocastra Lyophilised RCC Marker

12 April 2016

IVDs, cytopathology & histopathology

MHRA reference: 2016/004/012/601/002

Maquet: Cardiosave Hybrid/Rescue IABP

4 April 2016

Cardiac assist pumps

Model: 0998-00-0800-XX & 0998-UC-0800-XX

MHRA reference: 2015/012/022/292/006

Neuro Kinetics: Neuro-Otologic Test Center (NOTC)

27 May 2015

Optical, ophthalmic instruments & equipment

Model: NOTC-S, NOTC-O

MHRA reference: 2016/004/007/601/015

Ortho Clinical Diagnostics: VITROS 3600 & VITROS 5600

April 2016

IVDs, clinical chemistry

MHRA reference: 2016/004/012/601/001

Richard Wolf: Pump Tube

4 April 2016

Suction equipment

Model: suction system pump 8170,861

MHRA reference: 2016/004/008/701/009

Roche: cobas® EGFR Mutation Test v2

5 April 2016

IVD, genetic testing

MHRA reference: 2016/004/012/701/001

SiH Servicio Integral Hospitalario: Bundled Procedure Pack/ Ophthalmic Pack Q4009887/1

14 April 2016

Surgical devices, non-powered

MHRA reference: 2016/003/004/291/005

Siemens: Dimension Vista 500 / 1500 Intelligent Lab System

March 2016

IVDs, clinical chemistry

Model: 10488224 (500), 10444802 (1500)

MHRA reference: 2016/004/008/601/003

St. Jude Medical: Ellipse™ Implantable Cardioverter Defibrillator

6 April 2016

Implants, active, defibrillators

Model: CD1377-36C, CD1377-36QC, CD1411-36C, CD1411-36Q, CD2377-36C, CD2377-36QC, CD2411-36C, CD2411-36Q

MHRA reference: 2016/004/011/291/003

Terumo: CDI Blood Parameter Monitoring System 500, BPM

FSN 1509 2016-04

Infusion & transfusion, heart lung circuits

Model: CDI Blood Parameter Monitoring System 500, BPM 500AHCT & 500AVHCT

MHRA reference: 2016/004/012/701/006

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