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 .

Cellnovo: Cellnovo insulin pump system

28 January 2015

Device description: infusion systems

MHRA reference:

Codman, a J&J company: Codman庐 CERTAS 鈩� therapy management system

23 February 2015

Device description: diagnostic measurement and monitoring

Model: Codman庐 CERTAS 鈩� therapy management system

MHRA reference:

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

19 December 2014

Device description: cardiac assist pumps

MHRA reference:

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:

Invacare

24 February 2015

Device description: hoists and slings

Model: Birdie hoist

MHRA reference:

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:

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

24 February 2015

Device description: defibrillators, non-implantable

Model: various 鈥� see FSN for details

MHRA reference:

Medtronic CryoCath: FlexCath庐 Select Steerable Sheath

February 2015

Device description: vascular cannula and catheters

Model: 990065

MHRA reference:

Ortho Solutions: CIS PLATE

24 February 2015

Device description: osteosynthesis, bone plates

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

MHRA reference:

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

13 February 2015

Device description: IVDs, viral microbiology

MHRA reference:

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

Manufacturer reference: CPA291

Device description: surgical instruments, implant

Model: GAP-N48

MHRA reference:

Pharmaceutical Development Services: Thoracic vent procedure tray

25 February 2015

Device description: surgical devices, non-powered

MHRA reference:

RMS Rehabilitation Manufacturing Services

24 February 2015

Device description: buggies for disabled people

Model: Simba

MHRA reference:

Roche Diagnostics: Accu-Chek庐 Insight insulin pump cartridge

February 2015

Device description: infusion systems

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

MHRA reference:

Siemens Healthcare Diagnostics: ADVIA Centaur XPT

February 2015

Device description: IVDs, clinical chemistry

MHRA reference:

Van Os Medical: Excel Excite 4 Galaxy

02 February 2015

Device description: scooters, powered

MHRA reference:

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

24 February 2015

Device description: injection devices

MHRA reference:

Updates to this page

Published 27 February 2015