Field Safety Notices - 5 December - 9 December 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 5 December - 9 December 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
Abbott: ARCHITECT Active-B12
30 November 2016
IVDs, clinical chemistry
MHRA reference: 2016/012/002/701/010
Ascensia Diabetes Care Holdings: CONTOUR® DIABETES App
FAO 41
IVDs, self / home testing
Model: CONTOUR DIABETES App; NA
MHRA reference: 2016/012/002/701/003
Boston Scientific: INGEVITY™ MRI pace/sense lead
01 December 2016
Implants, active, leads and electrodes
Model: 7732, 7736, 7740, 7741 & 7742
MHRA reference: 2016/012/005/291/001
GE Medical: Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy,Precision 500D, ADVANTX and Innova 2000 systems.
GEHC Ref# FMI 10913
X-ray, digital acquisition systems
MHRA reference: 92016/012/005/291/0270
Hologic: ATEC Canister
SCAR-01037
Mammography
MHRA reference: 2016/011/002/701/011
Ortho Clinical: Multiple products attached list (ProdList GMDN)
01 November 2016
IVDs, blood transfusion
MHRA reference: 2016/011/030/601/004
Ortho Clinical: ORTHO VISION® and VISION® Max Analyzers for BioVue
December 2016
Blood grouping analyser
MHRA reference: 2016/012/002/601/008
Philips: IQon Spectral CT
14 November 2016
Computed tomography
Model: 728332
MHRA reference: 2016/012/008/291/002
Roche: PreciControl Varia
05 December 2016
IVDs, clinical chemistry
MHRA reference: 2016/012/008/701/014
Siemens: CentraLink® Data Management System
06 December 2016
IVDs, clinical chemistry
MHRA reference: 2016/012/006/601/008
Siemens: IMMULITE®2000/IMMULITE 2000XPi
24 November 2016
IVDs, clinical chemistry
Model: L2KPP2/L2KPP6 (SMN: 10381441 + 10381442)
MHRA reference: 2016/011/024/601/003
Siemens: SOMATOM Definition AS and SOMATOM Definition Flash
4 October 2016
Computed tomography
Model: 08098027 (SOMATOM Definition AS), 10430603 (Flash)
MHRA reference: 2016/012/007/601/006
Sysmex: Automated Blood Coagulation Analyzer CS-5100
02 December 2016
Coagulation
Model: CS-5100
MHRA reference: 2016/012/008/291/018
Tem Innovations: ROTEM® sigma complete+hep
15 November 2016
Coagulation
MHRA reference: 2016/011/030/701/001
Wright Medical Technology: Vis canulée Ø 2.3 mm L 22 mm, stérile VS2322
26 November 2016
Osteosynthesis, bone screws
MHRA reference: 2016/012/005/291/004
Zimmer: Nexgen TM Tibial Impactor Pad
05 November 2014
Orthopaedic surgical instruments - impacting tools
MHRA reference: 2014/011/007/701/007