Field safety notices - 23 to 27 February 2015

List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 February 2015.

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

You can see copies of field safety notices in our filecamp folder.

Cellnovo: Cellnovo insulin pump system

28 January 2015

Device description: infusion systems

MHRA reference: 2014/011/027/081/006

Codman, a J&J company: Codman® CERTAS ™ therapy management system

23 February 2015

Device description: diagnostic measurement and monitoring

Model: Codman® CERTAS ™ therapy management system

MHRA reference: 2015/002/003/081/003

Datascope: CS300, CARDIOSAVE and fiber-optic-upgraded IABPs

19 December 2014

Device description: cardiac assist pumps

MHRA reference: 2015/001/006/081/020

Intuitive Surgical

23 February 2015

Device description: surgical, diathermy

Model: da Vinci Si EndoWrist One Vessel Sealer instruments and da Vinci Xi EndoWrist Vessel Sealer instruments, 410322-05 and 480322-04

MHRA reference: 2015/002/024/081/010

Invacare

24 February 2015

Device description: hoists and slings

Model: Birdie hoist

MHRA reference: 2013/006/014/291/009

Leonhard Lang: Skintact, Cardionetics, Stable Base, Dalhausen

23 February 2015

Device description: ECG electrode

Model: 58009 Skintact F40; 58046 Skintact T60; 59629 Cardionetics W60; 50543 Skintact FSRB4; 50547 Stable Base T60; 58028 Skintact FS50; 58688 Dahlhausen W60.

MHRA reference: 2015/002/023/081/023

Leonhard Lang: corPatch-clip Neonaten,-easy Pedriatic,-easy neona

24 February 2015

Device description: defibrillators, non-implantable

Model: various – see FSN for details

MHRA reference: 2014/011/020/701/001

Medtronic CryoCath: FlexCath® Select Steerable Sheath

February 2015

Device description: vascular cannula and catheters

Model: 990065

MHRA reference: 2015/002/025/081/010

Ortho Solutions: CIS PLATE

24 February 2015

Device description: osteosynthesis, bone plates

Model: OS612130; OS613130; OS622130; OS623130; OS624130; OS633130; OS634130

MHRA reference: 2015/002/023/081/028

PathoFinder: RespiFinder RG Panel RespiFinder SMART 22 FAST v2.0

13 February 2015

Device description: IVDs, viral microbiology

MHRA reference: 2015/002/024/081/025

Pega Medical: GAP endo-exo medullary system / GAP nail

Manufacturer reference: CPA291

Device description: surgical instruments, implant

Model: GAP-N48

MHRA reference: 2015/002/023/081/024

Pharmaceutical Development Services: Thoracic vent procedure tray

25 February 2015

Device description: surgical devices, non-powered

MHRA reference: 2015/002/009/081/012

RMS Rehabilitation Manufacturing Services

24 February 2015

Device description: buggies for disabled people

Model: Simba

MHRA reference: 2015/001/022/401/008

Roche Diagnostics: Accu-Chek® Insight insulin pump cartridge

February 2015

Device description: infusion systems

Model: Accu-Chek Insight pump cartridge Po1 (pack of 1)

MHRA reference: 2015/002/020/131/007

Siemens Healthcare Diagnostics: ADVIA Centaur XPT

February 2015

Device description: IVDs, clinical chemistry

MHRA reference: 2015/002/026/601/007

Van Os Medical: Excel Excite 4 Galaxy

02 February 2015

Device description: scooters, powered

MHRA reference: 2013/012/010/081/026

Vygon UK: V-GREEN spinal needle 25G 90MM BX20, 0181.052

24 February 2015

Device description: injection devices

MHRA reference: 2015/002/026/601/002

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