Field Safety Notices - 30 January - 3 February 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 30 January - 3 February 2017
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
Atrium Medical
24 January 2017
Chest drains and accessories
Model: Thoracic catheters
MHRA reference: 2017/002/001/701/013
Bauch & Lomb: LazerEdge Knifes
1 February 2017
Surgical instruments, non-articulated cutting
Model: E7601
MHRA reference: 2017/002/001/701/014
Benson Viscometers
26 January 2017
IVDs, haematology
Model: BV200 Mk3
MHRA reference: 2017/001/030/299/001
Biomet: Oxford tibial resect body tube
16 January 2017
Orthopaedic surgical instruments - measuring tools
MHRA reference: 2017/001/018/291/040
Brainlab: iPlan RT Dose / iPlan RT
23 November 2016
Radiotherapy planning and verification systems
Model: iPlan RT Dose / iPlan RT; BrainSCAN (end-of-life)
MHRA reference: 2016/012/012/701/022
Brainlab: Brainlab Offset Cup Impactor Universal
22 December 2016
Orthopaedic surgical instruments - Impacting tools
Model: 52856, 52856A
MHRA reference: 2017/002/001/291/016
Cardiolex: Patient cable grabber (part of EC Sense)
30 January 2017
ECG
Model: Patient cable grabber
MHRA reference: 2017/002/001/291/026
Codman: Neurovascular embolization coil Neurovascular Embolization Coil Detacher
31 January 2017
Implants, non-active, embolisation products
Model: See "Attachment 1 - Catalogue numbers - commercial name_brand name_make
MHRA reference: 2017/002/002/299/006
CuraMedical: Curatamp
3 January 2017
Implants, non-active, vascular haemostasis device
Model: CT-140
MHRA reference: 2017/002/001/291/007
Dräger: Evita Infinity V500, Babylog VN500, Evita V300
January 2017
Lung ventilators
MHRA reference: 2017/002/001/291/023
GE Medical: Discovery MR450 1.5T narrow bore 1.5T non-GEM
FMI 60913
Magnetic resonance, equipment & accessories
Model: Discovery
MHRA reference: 2017/002/002/299/010
Medtronic: Medtronic Strata™ II/Strata™ NSC Valves (including Burr Hole and Lumbar Peritoneal [LP])
30 January 2017
Implants, non-active, hydrocephalus shunts
Model: 23042, 27739, 27740, 27788, 27794, 27812, 27814, 27815, 27816, 27817, 27818, 27819, 27820, 27821, 27822, 27823, 27824, 27825, 27827, 27922, 42335, 42355, 42365, 42836, 42856, 42866, 44420, 44421, 44430, 44465, 46070, 46075, 46080, 46085, 46655, 46665, 46836, 46856, 46866, 46871, 46876, 46881, 46886, 92355, 92365, 92856, 92866, 96655, 96665
MHRA reference: 2017/001/030/291/010
Philips: IntelliSpace Portal V6.5/Spectral Diagnostic Suite
14 November 2016
Computed tomography
Model: 8810051
MHRA reference: 2016/012/008/299/004
Roche: Anti-HAV
26 January 2017
IVDs, clinical chemistry
MHRA reference: 2017/001/030/701/014
Siemens: IMMULITE 2000/IMMULITE 2000 XPi Sex Hormone Binding Globulin (SHBG)
January 2017
IVDs, clinical chemistry
Model: L2KSH2 - SMN#: 10381198
MHRA reference: 2017/002/001/601/003
Smith & Nephew: Secura Protective Cream Z10 78g (CE)
31 January 2017
Barrier creams & sprays
MHRA reference: 2017/002/002/701/015