Field safety notices - 9 May - 13 May 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 9 - 13 May 2016
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
Alcon Laboratories: CENTURION® FMS Pack for CENTURION® Vision System
29 April 2016
Surgical devices, non-powered
Model: Please refer to attachment 1
MHRA reference: 2016/005/005/299/004
Covidien: Bravo pH Monitoring System and Accessories
3 May 2016
Implants, active, monitors and recorder MHRA reference: 2016/005/003/701/016
Medicina: Silo Bag
05 May 2016
Ostomy and continence equipment
Model: SBXX
MHRA reference: 2016/004/028/601/013
Medtronic: Verify External Neurostimulator
May 2016
Implants, active, stimulators, neuro
Model: 3531
MHRA reference: 2016/005/006/291/001
Nipro Diagnostics: TRUEresult/STADA Blood Glucose Test Strips (FAD)
02 May 2016
IVDs, self / home testing
MHRA reference: 2016/005/004/291/006
Philips: DigitalDiagnost
19 April 2016
X Ray, digital acquisition systems
Model: 712027, 712028, 712029, 712031, 712032, 712033
MHRA reference: 2016/005/009/299/017
Philips: DuraDiagnost
25 April 2016
X Ray, general Model: 712211
MHRA reference: 2016/005/010/299/001
Philips: DuraDiagnost
25 April 2016 (FCO71200131)
X Ray, general Model: 712214
MHRA reference: 2016/005/010/299/002
Philips: MX 16-slice
April 2016
Computed tomography Model: 728131, 728132, 728135 MHRA reference: 2016/005/009/299/011
Pioneer Surgical Technology: Nunec Cervical Arthroplasty Device
05 May 2016
Spinal implants
Model: 73-MD-7
MHRA reference: 2016/005/005/601/006
Polymer Technology Systems: PTS Panels CHOL+HDL+GLU
4 February 2016
IVDs, self / home testing
MHRA reference: 2016/004/027/701/002
Schiller AG: FRED Easyport
08 March 2016
Defibrillators, non-implantable
Model: 0.900000
MHRA reference: 2016/003/030/291/001
Siemens Medical Solutions: E.CAM and Symbia family of gamma camera systems
MI001/16/S and MI002/16/S
Nuclear medicine, Gamma camera systems & accessories
Model: Various
MHRA reference: 2016/005/006/601/002
Siemens: ADVIA Centaur XPT
April 2016
IVDs, clinical chemistry
Model: 10711433
MHRA reference: 2016/005/004/601/005
Siemens: ADVIA Centaur TnI-Ultra
May 2016
IVDs, clinical chemistry
MHRA reference: 2016/005/009/601/001
Zimmer: Various knee and hip implants
04 May 2106
Central sterilisation services materials
MHRA reference: 2016/005/004/291/012
bioMérieux: Multiple product - See Table I
10 May 2016
IVDs, viral microbiology
MHRA reference: 2016/005/011/299/003 0 attachments