Field Safety Notice - 15 to 19 January 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 January 2018
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 c4000 / c8000 / c16000 cuvette segments
8 December 2018
IVDs, clinical chemistry
MHRA reference: 2018/001/011/291/003
Ad-Tech Medical Instrument Corporation: Disposable Drill Kit
03 January 2018
Surgical power tools
Model: DDK2-2.4-30X, DDK2-2.8-30X
MHRA reference: 2018/001/005/601/008
Baxter: PrisMax Hemodialysis Machine 115369
27 June 2017
Dialysis, haemofilters
MHRA reference: 2017/006/019/291/028
Creganna Medical (Boston Scientific): Zurpaz Steerable Sheath Set
02 June 2017
Vascular cannula and catheters
MHRA reference: 2017/005/031/601/007
Greiner Bio-One: MiniCollect® Complete 1 ml 9NC
18 January 2018
IVDs, specimen receptacles
Model: 450556
MHRA reference: 2018/001/018/291/019
Hocoma: Andago V2.0
CAPA-2347
Therapy, Standing & Walking
MHRA reference: 2018/001/016/291/010
Maquet (Gentinge): VOLISTA
26 December 2017
Lamps & lights
Model: All VOLISTA StandOP, Triop and Access surgical lights
MHRA reference: 2018/001/005/291/011
Medtronic: AFFINITY® NT Cardiotomy/Venous Reservoir (CVR) Stand-Alone
January 2018
Infusion & transfusion, heart lung circuits
Model: 95249, 61399409462
MHRA reference: 2018/001/017/291/012
Philips Medical Systems: Allura Xper Systems
20 December 2017
X ray, fluoroscopy systems
Model: 722001, 722002, 722003, 722010, 722026, 722005, 722011, 722027, 722006, 722012, 722028, 722008, 722013, 722015, 722023, 722035, 722020, 722029, 722038, 722039, 722058, 722059
MHRA reference: 2018/001/012/291/002
Philips Medical Systems: Brilliance CT Big Bore
02 January 2018
Computed tomography
Model: Brilliance Big Bore Oncology CT– 728243, Brilliance Big Bore Radiology CT- 728244
MHRA reference: 2018/001/015/291/016
QIAGEN: therascreenPyrosequencing assays
16 January 2018
IVD, genetic testing
MHRA reference: 2018/001/018/291/012
Radiometer: PICO70
FAN 915-377
Storage & collection devices
MHRA reference: 2018/001/011/291/007
Rocialle: IV Cannulation Pack - Barnsley District
19 January 2018
Bandages and tapes
Model: RML112-180
MHRA reference: 2018/001/019/291/001
Smiths Medical: Medfusion® Model 3500; Medfusion® Model 4000
12 January 2018
Infusion systems
MHRA reference: 2018/001/015/291/002
Smith & Nephew: RT-PLUS MOD FEMORAL COMP. RIGHT 4 CEM RT-PLUS FEMORAL COMPONENT RIGHT 4 CEM
15 January 2018
Joint prosthesis, knee
MHRA reference: 2018/001/016/291/011