Field safety notices - 7 to 11 September 2015
List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 September 2015.
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
Aesculap AG: METHA titanium cone adapter (neck)
21 August 2015
Joint prosthesis, hip
Model: METHA NECK 12/14 - different CCD-angles; NC077T NC078T NC079T NC087T NC088T NC089T NC097T NC098T NC099T
MHRA reference: 2015/008/020/291/025
Alba Bioscience: ALBAclone Anti-Leb
7 September 2015
IVDs, blood transfusion
Model: Z217
MHRA reference: 2015/009/007/601/003
Baxter Healthcare SA: INFUSOR patient control module 0.5ml
September 2015
Infusion systems
MHRA reference: 2015/009/010/292/003
ConforMIS, Inc.: knee replacement systems: ConforMIS iTotal, iUni, and iDuo iJigs
6 September 2015
Surgical instruments, implant
MHRA reference: 2015/009/007/291/011
CME Limited: BodyGuard 575 PCA infusion pump
21 July 2015
Infusion systems
Model: 100-424PXS
MHRA reference: 2015/009/008/291/005
Dako Denmark A/S: EnVision FLEX
CAPA00544
IVDs, cytopathology & histopathology
Model: K8000, K8002 and GV800
MHRA reference: 2015/009/007/292/001
Depuy Synthes: application instrument for sternal ZIPFIX
18 August 2015
Surgical instruments, implant
MHRA reference: 2015/009/007/299/004
Edwards Lifesciences LLC: ThruPort knot pusher and valve placement pack
26 August 2015
Surgical instruments, manipulating
Model: VPP (valve placement pack including KP1 knot pusher)
MHRA reference: 2015/009/007/299/001
GE Medical Systems LLC: GE Healthcare 3.0T MR systems
1 September 2015
Magnetic resonance, equipment & accessories
MHRA reference: 2015/009008/292/006
Impac Medical Systems, Inc: Monaco
FCA-IMS-0009
Radiotherapy planning and verification systems
MHRA reference: 2015/009/010/292/010
iMDsoft Ltd: MetaVision suite, clinical information system
August 2015
Monitors, patient
MHRA reference: 2015/008/017/081/005
Leica Biosystems: Novocastra reagent
03 September 2015
IVDs, cytopathology & histopathology
Model: CD10-270-CE and CD10-270-CE-S
MHRA reference: 2015/009/003/601/006
Liko AB - Hill-Rom Lulea: Viking 300, Viking M, Viking L, Viking XL
Mod 1228
Hoists and slings
Model: Viking 300, Viking M, Viking L, Viking XL: 2040003, 2040004, 2040005, 2040015, 2040035.
MHRA reference: 2015/006/026/051/006
Pennine Healthcare: Endo-Modell Tibiaplateau sets und Ersatzteilsets
September 2015
Joint prosthesis, knee
Model: Total Knee Replacement 15-0027/11
MHRA reference: 2015/009/008/291/004
Roche Diabetes Care: Accu-Chek Insight
SB_RDC_2015_05
Infusion systems
Model: 00700006889 00700006889
MHRA reference: 2015/008/019/701/009
Roche Diagnostics: cobas b 123 sensor cartridge BG/ISE/GLU/LAC
04 September 2015
IVDs, extra laboratory testing
MHRA reference: 2015/009/008/701/014
Samsung Electronics Co: mobile digital X-ray GM60A
GM60A-150831-1
X-ray, digital acquisition systems
Model: GM60A-32S, GM60A-40S
MHRA reference: 2015/009/007/292/002