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
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
Waldemar Link: Endo-Model tibial plateau sets and Endo-Model replacement sets
18 August 2015
Joint prosthesis, knee
Model: 15-0027/11
MHRA reference: 2015/008/019/291/005