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

View the 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

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