Field safety notices - 27 April to 01 May 2015

List of field safety notices (FSNs) from medical device manufacturers from 27 April to 1 May 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

bioMerieux: MYLA

28 April 2015

IVDs, Bacteriology

MHRA reference: 2015/004/029/291/016

Boston Scientific: Extractor™ Pro RX Retrieval Balloon Catheter

29 April 2015

Surgical instruments, minimal access

Model: M00547000

MHRA reference: 2015/004/030/291/003

CareFusion 211: AVEA Ventilator

21 April 2015

Lung ventilators

MHRA reference: 2015/004/028/131/001

CooperSurgical Inc: WarmGel® Infant Heel Warmer

05 March 2015

Heating, patient, electrical pads & blankets

Model: 20418

MHRA reference: 2015/004/027/291/013

CooperSurgical Inc: TransWarmer Infant Transport Mattress

07 April 2015

Heating, patient, electrical pads & blankets

Model: 20421

MHRA reference: 2015/004/027/291/014

Covidien: Devon™ Light Glove

23 April 2015

Lamps and lights

MHRA reference: 2015/004/023/701/005

Gainsborough Bathrooms: Gainsborough Bathrooms

April 2015

Bath and Aids

Model: Kent

MHRA reference: 2015/003/010/601/006

Gerium Medical: BiliCare

10 March 2015

Diagnostic measurement and monitoring

MHRA reference: 2015/004/024/291/001

Instrumentation Laboratory S.p.a: ILab Test Magnesium

April 2015

IVDs, clinical chemistry

MHRA reference: 2015/004/024/291/002

Integra LifeSciences

22 April 2015

Monitors, patient

Model: Camino (CAM02) and Licox (LCX02 and LCX02R)

MHRA reference: 2015/004/027/291/010

Kimal: Kimal procedure packs containing Devon™ Light Glove

29 April 2015

Surgical devices, non-powered

Model: Various

MHRA reference: 2015/004/029/601/015

Medtronic: SynchroMed® II Implantable Drug Pumps

23 April 2015

Implants, active, infusion pumps

Model: 8637-20, 8637-40

MHRA reference: 2015/004/014/291/013

Ortho-Clinical Diagnostics: ORTHO VISION™ Analyser

April 2015

IVDs, blood transfusion

MHRA reference: 2015/004/023/601/008

Philips Medical Systems: EPIQ 5, EPIQ 7, Affiniti 50, Affiniti 70

13 May 2015

Ultrasound, imaging

MHRA reference: 2015/004/029/291/013

Philips Medical Systems: EPIQ 5, EPIQ 7, Affiniti 50, Affiniti 70

14 April 2015

Ultrasound, imaging

MHRA reference: 2015/004/029/291/017

Philips Medical Systems: QLAB for Xcelera

17 March 2015

Ultrasound, Imaging

Model: QLAB 10.0

MHRA reference: 2015/004/029/291/003

Scopeguard

29 April 2015

Endoscopes, rigid

Model: Scopeguard Cystoscope Sheath

MHRA reference: 2015/004/022/601/008

Siemens Healthcare Diagnostics: Dimension Vista® LOCI Thyroid Stimulating Hormone

April 2015

IVDs, clinical chemistry

Model: K6421 (SMN 10445104)

MHRA reference: 2015/004/027/601/001

Siemens Healthcare Diagnostics: IMMULITE 2000, MMULITE 2000XPi

April 2015

IVDs, clinical chemistry

Model: Reagent Carousel Temperature Sensor Printed Circuit Board

MHRA reference: 2015/004/029/601/001

Spectron Gas Control Systems: Multimed Light valves

19 March 2015

Gas cylinders

MHRA reference: 2015/004/029/291/007

Vascular Solutions Inc: Vari-Lase Laser Fiber and Procedure Kit

EU-2015-01C

Therapy, lasers

MHRA reference: 2015/004/027/291/015

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