Field safety notices - 21 to 25 September 2015
List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 September 2015.
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
Becton Dickinson: BD Plastipak syringe/ BD oral syringe
September 2015
Injection devices
MHRA reference: 2015/009/022/601/003
BioLytical Laboratories: INSTI HIV-1/HIV-2 antibody test kit
14 August 2015
IVDs, viral microbiology
MHRA reference: 2015/009/017/601/001
BrainLAB Germany: patient data manager
27 August 2015
Picture archiving and communication system (PACS)
MHRA reference: 2015/009/022/292/003
DePuy Orthopaedics: specialist 2 intramedullary (SP2 IM) rod 400mm instrument
September 2015
Surgical instruments, implant
Model: 966120
MHRA reference: 2015/009/023/081/001
NRS Healthcare: NRS 4 Wheel rollators (item numbers M99266 and M99278)
M99266 and M99278
Walking aids, rollators
MHRA reference: 2015/009/021/081/003
Pacific Hospital Supply Co: pediatric enteral feeding tube
18 September 2015
Enteral feeding set
MHRA reference: 2015/009/017/181/001
Philips Medical Systems BV: Allura Xper FD
7 September 2015
X-ray, fluoroscopy systems
Model: 722001, 722002, 722003
MHRA reference: 2015/009/022/292/001
Prism Medical Ltd: Prism P136, C136 and CP136
25 September 2015
Hoists and slings
Model: FSG136 (gantry) & P136 (hoist motor) & P136 trolley wheel set
MHRA reference: 2015/007/027/401/007
Randox Laboratories: liquid chemistry premium plus control
22 September 2015
IVDs, clinical chemistry
Model: LUE5095
MHRA reference: 2015/009/022/601/005
Siemens: Cios Alpha mobile C-arm X-ray system
UI XP038/15/S & UI XP037/15/S
X ray, fluoroscopy systems
Model: 10308191
MHRA reference: 2015/008/017/601/004
Single Use Surgical: forceps
22 September 2015
Surgical instruments, articulated holding
Model: S221
MHRA reference: 2015/009/017/601/003
Spacelabs Healthcare: Arkon anesthesia delivery system
17 April 2015
Anaesthetic machines & monitors
Model: 99999
MHRA reference: 2015/009/023/292/012
Spacelabs Healthcare: Ultraview SL Command Module
27 April 2015
Monitors, patient
Model: 91496
MHRA reference: 2015/009/024/181/004
Thermo Fisher: tests based on trinder reactions
22 September 2015
IVDs, clinical chemistry
MHRA reference: 2015/009/022/292/007
Vygon (UK): Y connector 8-10mm
16 September 2015
Infusion and transfusion, administration sets
Model: 0884.08
MHRA reference: 2015/007/003/601/501