Field Safety Notice - 19 to 23 February 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 February 2018
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: COULTER EPICS & FC 500™ Series Flow Cytometers
17 January 2018
IVDs, haematology
MHRA reference: 2018/001/019/601/003
Haemonetics: Bloodtrack Manager / Courier / Emerge
16 February 2018
Blood refrigerators
MHRA reference: 2018/002/019/291/010
Ion Beam Application Dosimetry: ProteusPLUS and proteusONE
16 February 2018
Radiotherapy
Model: Proteus 235
MHRA reference: 2018/002/016/291/013
IBL International
02 February 2018
IVDs, clinical chemistry
MHRA reference: 2018/002/002/000/012
Jiangsu Dynamic Medical Technology: DU893 Portable Dental Unit / DYNAMIC/Dynamic Medical
November 2017
Dental, laboratory equipment
MHRA reference: 2018/002/006/291/001
Mast Group Ltd: MPM-AUG32 Mast Uri Plates
16 February 2018
IVDs, bacteriology
MHRA reference: 2018/002/020/601/005
Medica: REXSYS 27H
11 December 2017
Dialysis, haemodialysis
MHRA reference: 2018/002/020/291/006
Roche Diagnostics GmbH: 03337111001
09 February 2018
IVDs, extra laboratory testing
Model: Cobas b 221 systems equipped with AutoQC module
MHRA reference: 2018/002/014/478/011
Smiths Medical: Medfusion® Model Series 3010, 3500, 4000
20 February 2018
Infusion systems
Model: 880.5725 Infusion Pump
MHRA reference: 2018/002/019/291/002
Southmedic: EtCO2 OxyMask
14 February 2018
Breathing system components
Model: OK-2125-8, OM-2125-14, OM-2125-8, OM-2325-8, OP-2125-8
MHRA reference: 2018/002/019/478/007
Stryker: Triathlon® Knee System 5mm & 10mm Tibial Augment
February 2018
Joint prosthesis, knee
MHRA reference: 2018/002/009/701/014
SynCardia Systems: Freedom Driver System
December 2017
Implantable ventricular assist devices
Model: 595000-001
MHRA reference: 2017/011/030/601/015