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

View the 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

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