Field Safety Notice - 18 to 22 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 September 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
View the latest FSNs
Aaren Scientific: EC-3 Posterior Chamber Hydrophobic Acrylic Lens
20 September 2017
Lens intraocular
Model: EC-3
MHRA reference: [2017/009/001/291/013]
Hyphen BioMed
06 September 2017
Coagulation
Model: Biophen Arixtra Control
MHRA reference: [2017/009/019/701/009]
Insight Medical: Voice Prosthesis Brush
18 September 2017
Implant, voice prosthesis
Model: PB/50
MHRA reference: [2017/009/019/601/008]
Lifecell: Revolve™ System
19 September 2017
Suction equipment
MHRA reference: [2017/009/019/291/012]
Leica: Proveo 8
12 September 2017
Surgical equipment, miscellaneous
MHRA reference: [2017/009/018/701/004]
Limacorporate: Delta cup beater-positioner-aligner
15 September 2017
Orthopaedic surgical instruments - insertion/extraction tools
Model: 9057.20.555
MHRA reference: [2017/009/019/701/013]
Medex International
12 September 2017
Prostheses
Model: 3S14
MHRA reference: [2017/006/020/401/004]
Pega Medical: GAP ENDO-EXO MEDULLARY SYSTEM / GAP NAIL DRIVER
09 September 2017
Orthopaedic surgical instruments – Insertion/extraction tools
Model: GAP-NDR100
MHRA reference: [2017/009/019/601/006]
Permobil AB: Permobil
26 July 2017
Wheelchairs, powered
Model: C300, C350, C400 and C500 with seats Corpus II, Corpus II LR, Corpus KB and Base Only
MHRA reference: [2017/009/004/701/002]
Philips: Philips SureSigns VSi / SureSigns VS2+
September 2017
Monitors, patient
Model: SureSigns VSi : 863275, 863276, 863277 SureSigns VS2+ : 863278, 863279
MHRA reference: [2017/009/021/291/029]
Quantel Medical: Easyret
07 April 2017
Therapy, lasers
Model: Easyret; PABX0017 and PABX0016
MHRA reference: [2017/009/019/601/002]
SD Biosensor
07 September 2017
IVDs, self / home testing
Model: MultiCare™ Analyzer/ Lumiratek C
MHRA reference: [2017/009/020/601/001]
Smiths Medical: Medfusion® Model 3500; Medfusion® Model 4000
August 2017
Infusion systems
Model: 880.5725 Infusion Pump
MHRA reference: [2017/006/029/291/008]
Spiegelberg: External Ventricular Drainage Kit/External Ventricular Drainage Kit
with Plate and Clamp
05 September 2017
Cerebrospinal fluid drainage, external
Model: EVD30.001.01/EVD3O.004.01
MHRA reference: [2017/009/011/701/004]