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