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

View the 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

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

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