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
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