Field safety notices - 17 to 21 August 2015

List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 August 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

Alcon Laboratories: LX3 microscope floor stand

13 August 2015

Surgical equipment, miscellaneous

MHRA reference: 2015/008/014/081/010

Bayer Medical Care: Medrad Mark 7 Arterion injection system

July 2015

Media injectors

MHRA reference: 2015/008/017/081/006

Becton Dickinson Diagnostics: BD Vacutainer Eclipse Signal blood collection needle with integrated holder

17 August 2015

Storage & collection devices

Model: 368835 / 368836

MHRA reference: 2015/008/017/601/001

Biomet: narrow right angle large driver tip (hexed)

August 2015

Surgical instruments, implant

MHRA reference: 2015/008/017/081/004

BrainLAB: ExacTrac patient positioning system v. 6.0.0 - 6.0.5

20 July 2015

Radiotherapy

MHRA reference: 2015/008/014/292/042

BrainLAB: disposable reflective marker spheres

23 July 2015

Surgical navigation system

Model: 41773G; 41774G; 41772G

MHRA reference : 2015/008/018/291/003

Medicina: Medicina enteral syringe pumps

07 August 2015

Feeding systems and tubes

Model: P500, P700 and P900

MHRA reference: 2015/008/014/601/007

Molnlycke Health Care Group: ConvaTec suction tube

28 July 2015

Suction equipment

MHRA reference: 2015/008/014/292/045

Spacelabs Healthcare: Spacelabs patient monitor

05 September 2014

Monitors, patient

Model: 91367, 91369, 91370, 91387, 91393

MHRA reference: 2015/008/014/081/018

St. Jude Medical: Atrial implantable cardioverter defibrillator

18 August 2015

Implants, active, defibrillators

Model: All models of RF enabled St. Jude Medical Ellipse, Fortify Assura, Unify Assura, and Quadra Assura implantable cardioverter defibrillators (ICDs) and Assurity and Allure pacemakers when used with Merlin@home RF remote monitoring transmitter model EX1150.

MHRA reference: 2014/012/016/081/031

Volcano: Pioneer Plus catheter

31 July 2015

Ultrasound, imaging

Model: PPlUS 120

MHRA reference: 2015/008/014/292/038

18 August 2015

Joint prosthesis, knee

Model: 15-0027/11

MHRA reference: 2015/008/019/291/005

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