Field safety notices - 21 March to 25 March 2016
List of field safety notices (FSNs) from medical device manufacturers from 21 March to 25 March 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
B Braun: Dialog, Dialog Advanced, Dialog+
21 March 2016
Dialysis, haemodialysis
Model: please see annex 1
MHRA reference: 2016/003/021/292/001
Eckert & Ziegler BEBIG: SagiNova
18 March 2016
Radiotherapy, Afterloading
Model: SagiNova, SagiNova Ir
MHRA reference: 2016/003/022/292/023
Navilyst Medical: Vaxcel PICC, Xcela PICC & BioFlo PICC
14 March 2016
Vascular cannula and catheters
MHRA reference: 2016/003/022/291/001
Nipro Corporation: Elisio-19H
24 March 2016
Dialysis, haemodialysis
Model: Dialyser ELI-19H-GC
MHRA reference: 2016/003/024/292/018
Ortho Clinical Diagnostics: VITROS Total β-hCG II Reagent Pack
21 March 2016
IVDs, extra laboratory testing
MHRA reference: 2016/002/023/601/003
Philips: Extended Brilliance WorkSpace NM 2.0
04 March 2016
Computed tomography
Model: 882489-Extended Brilliance Workspace NM 882488-EBW NM Special
MHRA reference: 2016/003/018/292/003
Radiometer: AQURE system
FAN 915-350
IVDs, extra laboratory testing
Model: FLEXLINK (933-504)
MHRA reference: 2016/003/022/292/003
Teleflex Medical: Perfusion Catheter
16 March 2016
Vascular cannula and catheters
MHRA reference: 2015/008/019/601/013
The Learning Clinic: VitalPAC
02 February 2016
Diagnostic measurement and monitoring
Model: v3.0 onwards
MHRA reference: 2016/003/017/601/004
Ortho-Clinical Diagnostics: TCAutomation /enGen Laboratory Automation System TCA Recapper: 952036-EG
18 March 2016
IVDs, clinical chemistry
MHRA reference: 2016/003/018/601/017
Thermofisher: Oxoid Nitrocefin (+ Reconstitution Fluid Batch)
15 March 2016
IVDs, bacteriology
Model: SR0112C
MHRA reference: 2016/003/016/601/009
TRUMPF: Double joint strut, OR Adapter; OR Extension
21 March 2016
Operating table
Model: please see FSN
MHRA reference: 2016/003/023/701/001
Vascular Solutions: Guardian II hemostasis valve
09 March 2016
Vascular cannula/catheter accessories
Model: Guardian II hemostasis valve FH101, FH101-T, FH101-25, FH101-50
MHRA reference: 2016/003/014/292/006