Field Safety Notice - 15 to 19 May 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 15 May - 19 May 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
Beckman Coulter: Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor; Refer to section 8
17 May 2017
IVDs, clinical chemistry
Model: Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor; Not applicable
MHRA reference: 2017/005/017/601/007
Biomet: T.E.S.S. Reverse Shoulder System
11 May 2017
Joint Prosthesis, Shoulder
MHRA reference: 2017/005/012/701/016
Covidien: Endo Peanut Auto Suture Blunt Dissector 5mm
12 May 2017
Surgical instruments, minimal access
Model: Endo Peanut Auto Suture Blunt Dissector 5mm
MHRA reference: 2017/005/015/291/011
Datex-Ohmeda: Carestation 620, Carestation 650, Carestation 650c
FMI 34082
Anaesthetic machines & monitors
MHRA reference: 2017/005/017/701/008
Medtronic: KYPHON® Directional Bone Filler
May 2017
Bone Cement and tools
MHRA reference: 2017/005/018/291/014
Medtronic: NavLock™ Tracker (part of below NavLock™ instrument sets and kits)
May 2017
Surgical navigation system
Model: 9734228, 9734259, 9734315, 9734489, 9734590, 9734682, 9734683, 9734734, 9734833, 9734837, 9734906, 9734907, 9734908, 9734914, 9735120
MHRA reference: 2017/005/018/291/001
Merck: Bioscot
12 May 2017
IVDs, blood transfusion
Model: Bioscot; Monoclonal Control Reagent
MHRA reference: 2017/004/021/601/002
Microgenics: Various Microgenics Application Sheets
16 May 2017
IVDs, clinical chemistry
Model: assay application sheets
MHRA reference: 2017/005/016/601/005
Philips: V60 Ventilator
20 April 2017
Lung Ventilators
MHRA reference: 2017/005/015/291/006
Roche: cobas® 6800 System / cobas® 8800 System
10 May 2017
IVDs, viral microbiology
Model: 05524245001 / 05412722001
MHRA reference: 2017/005/016/701/016
Sendal: 2-WAY EXT.LINE FOR PCA, BCV,ROT.L.LOCK
15 May 2017
Infusion & transfusion, administration sets
Model: PCA-01
MHRA reference: 2016/002/017/292/008
Siemens: RAPIDLab 348 Gas cartridge pack
May 2017
IVDs, Extra Laboratory Testing
MHRA reference: 2017/005/015/601/006
Siemens: N Protein Standard SL; N/T Protein Control SL
May 2017
IVDs, clinical chemistry
MHRA reference: 2017/005/016/701/014
Siemens: Dimension Vista PROT1CAL & PROT1 CON ( L & M & H)
May 2017
IVDs, clinical chemistry
MHRA reference: 2017/005/016/701/018
Vapotherm
23 March 2017
Humidifiers
Model: PF-UNIT Vapotherm Precision Flow
MHRA reference: 2017/004/003/701/015