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
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