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
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