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

Published 25 September 2017