Field safety notices - 1 to 5 February 2016

List of field safety notices (FSNs) from medical device manufacturers from 1 February to 5 February 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: MitraClip Clip Delivery System MSK02ST, containing CDS02ST Clip Delivery System and SGC01ST Steerable Guide Catheter

4 February 2016

Implants, non active, cardiovascular heart valves

MHRA reference: 2016/002/004/292/002

Accriva Diagnostics: ProTime InRhythm Cuvettes

27 January 2016

Coagulation

Model: RHY-PT50

MHRA reference: 2016/002/002/292/013

Arkray Factory: 1) SPOTCHEMII Glucose (IVD) 2) SPOTCHEM II PANEL-1 (IVD) 3) SPOTCHEM II PANEL-V (IVD 4) SPOTCHEMII Glucose (MEN) 5) SPOTCHEM II PANEL-1 (MEN)

28 January 2016

IVDs, extra laboratory testing

Model: 1) SPOTCHEMII Glucose (IVO) :77160

2) SPOTCHEM II PANEL-1 (IVO):77184

3) SPOTCHEM II PANEL-V (IVO):77189

4) SPOTCHEMII Glucose (MEN):33905

5) SPOTCHEM II PANEL-1 (MEN):33927

6) SPOTCHEM II PANEL-V (MEN):32138

MHRA reference: 2016/002/003/292/012

Ascensia: Contour Next blood glucose test strips

PQSC 2016-01

IVDs, self / home testing

MHRA reference: 2016/001/028/292/008

Corin: Trinity Acetabular Shell

3 February 2016

Joint prosthesis, hip

MHRA reference: 2016/002/003/601/002

Covidien: Puritan Bennett 980 Ventilator

2 February 2016

Lung ventilators

MHRA reference: 2016/002/001/701/018

Dräger Medical GmbH

January 2016

Lung ventilators

Model: Evita Infinity V500, Babylog VN500, Evita V300

MHRA reference: 2016/002/003/292/017

IDS France SAS: IDS-iSYS and TGS TA

7 December 2015

IVDs, clinical chemistry

MHRA reference: 2015/012/021/291/004

Instrumentation Laboratory Co.: HemosIL Plasminogen

December 2015

Coagulation

Model: HemosIL Plasminogen

MHRA reference: 2016/001/029/292/019

ITD GmbH: Monitor mounts and support arms

December 2015

Monitors, Patient

Model: Rotatable VESA 75 / 100 adaptation;TH.0124.800 and TH.0124.991

MHRA reference: 2016/001/021/181/003

Ivoclar Vivadent: 558521 (Refill) and 558520 (Assortment)

January 2016

Dental materials

Model: Helioseal Clear

MHRA reference : 2016/002/003/292/013

Philips Medical Systems: Philips IntelliVue Information Center iX

January 2016

Monitors, Patient

Model: 866023 IntelliVue Info Center iX, A.0, 866117 PIIC Classic Upgrade, 866389 IntelliVue Info Center iX, B.0

MHRA reference: 2015/011/030/292/012

Roche Diagnostics: Please see below under “Accessories”

26 January 2016

IVDs, self / home Testing

MHRA reference: 2016/001/029/701/003

Samsung Electronics: PT Renal Test 6

FSCA_PT10-1215001-1

IVDs, clinical chemistry

Model: PT10

MHRA reference: 2016/001/029/292/018

SEBIA: CAPILLARYS 3 TERA

17 December 2015

IVDs, clinical chemistry

MHRA reference: 2015/012/024/291/013

Siemens: CLINITEK Status + Connect System 2.60/2.4.0.0 (2.61/2.4.1.0) software upgrade kit

January 2016

IVDs, clinical chemistry

MHRA reference: 2016/001/029/601/004

Villa Sistemi Medicali: Apollo I DRFI EZ I EZ DRF; Clinodigit EVa, JunoDRF

15 January 2016

X Ray, fluoroscopy systems

MHRA reference: 2016/001/022/291/001

Zimmer: Metasul ®

Femoral Head 40 S / -3.5 Taper 12/14, LPS-FLEX PRECOAT FEMORAL A-L

25 January 2016

Joint prosthesis, hip

MHRA reference: 2016/001/027/071/001

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