Field safety notices - 31 August to 4 September 2015
List of field safety notices (FSNs) from medical device manufacturers from 31 August to 4 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
Boston Scientific Corporation: WATCHMAN™ left atrial appendage (LAA) closure device with delivery system and WATCHMAN™ access system
28 August 2015
Implants, non-active, cardiac appendage and septal defect occluders / plugs
MHRA reference: 2015/008/027/081/002
Ethicon: Temporary cardiac pacing wire
3 September 2015
Pacemakers, external
MHRA reference: 2015/009/003/291/005
Eurovema AB: Pixi
1 June 2015
Buggies for disabled people
MHRA reference: 2015/009/001/291/015
Halyard Health: Kimvent closed suction system
EMEA5225
Suction equipment
MHRA reference: 2015/008/028/291/001
Hitachi Medical Corporation: AIRIS Vento
17 August 2015
Magnetic resonance, equipment and accessories
Model: AIRIS Vento, AIRIS Vento LT, APERTO Eterna, APERTO Lucent, Echelon, OASIS
MHRA reference: 2015/008/024/291/016
IMPAC Medical Systems: XiO RTP system
FCA-IMS-0008
Radiotherapy planning and verification systems
MHRA reference: 2015/008/028/291/029
Medtronic CryoCath: CryoConsole
2 September 2015
Surgical, cryogenic
Model: 106E2
MHRA reference: 2015/009/002/291/009
Olympus KeyMed: Olympus instrument channel adaptor
1 September 2015
Endoscopes, flexible
Model: MAJ-1606
MHRA reference: 2015/009/002/292/007
Philips Healthcare Inc: HeartStart XL+ defibrillator/monitor
June 2015
Defibrillators, non-implantable
Model: 861290
MHRA reference: 2015/007/020/121/004
Philips Medical Systems BV: Allura Xper FD
18 August 2015
X-ray, fluoroscopy systems
Model: 722026, 722027, 722028, 722029, 722038, 722058, 722033, 722034, 722035, 722036, 722039, 722059
MHRA reference: 2015/009/001/291/016
Stryker Orthobiologics: Aliquot delivery kits (syringe and plunger)
27 August 2015
Surgical instruments, implant
MHRA reference: 2015/008/028/291/002
Siemens Healthcare Diagnostics: ADVIA Chemistry XPT system
August 2015
IVDs, clinical chemistry
Model: SMN 10723034
MHRA reference: 2015/009/002/601/007
The Anspach Effort: G1 dissection tools
30 July 2015
Surgical power tools
Model: various models
MHRA reference: 2015/008/028/291/024
Thermofisher Scientific: Sensititre
11 August 2015
IVDs, clinical chemistry
Model: CP114-10; CP112-10; T3462; T3462-10
MHRA reference: 2015/009/003/601/001