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