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
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