Field safety notices - 7 March to 11 March 2016
List of field safety notices (FSNs) from medical device manufacturers from 7 March to 11 March 2016.
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
Abrasive Technology: Prodia
8 January 2016
Surgical power tools
MHRA reference: 2016/003/009/292/013
AB SCIEX Pte: 3200MD series and 4500MD series
4 March 2016
IVDs, clinical chemistry
Model: API 3200MD™ LC/MS/MS System, 3200MD QTRAP® LC/MS/MS System, Triple Quad™ 4500MD LC/MS/MS System, QTRAP® 4500MD LC/MS/MS System
MHRA reference: 2016/003/010/292/032
Arjo: Akron Deluxe Tilt Table
18 January 2016
Trolleys and chairs
Model: 8652XXXX, 8652TXXXX
MHRA reference: 2015/012/016/701/002
ArthroCare Corporation: TOPAZ Microdebrider
4 March 2016
Surgical, diathermy
MHRA reference: 2016/003/007/291/002
Bayer Healthcare: Essure
29 February 2016
Implants, non-active, contraceptive implants
Model: Essure 305
MHRA reference: 2016/003/007/292/022
Dexcom: G4 PLATINUM and GS Mobile receiver
February 2016
Continuous Glucose Monitoring Systems (CGMS)
Model: MT20649-1, MT20649-2, MT22719-1, MT22719-2
MHRA reference: 2016/002/025/291/005
Direct Flow Medical: DFM Transcatheter Aortic Valve System
22 July 2015
Implants, non-active, cardiovascular heart valves
MHRA reference: 2015/007/029/291/007
GE Medical Systems
FMI34075
Anaesthetic machines & monitors
Model: Aisys CS2
MHRA reference: 2016/003/010/292/031
GE Medical: Lightspeed 16, Discovery ST PET-CT Imaging System, LightSpeed Ultra, Discovery LS PET-CT Imaging System, and LightSpeed Pro 16
FMI25467
Computed tomography system
MHRA reference: 2016/003/008/291/003
Integra: Monopolar Instruments & Bipolar Instrument Handle
4 March 2016
Surgical, diathermy
Model: CEV649B5
MHRA reference: 2016/003/008/291/001
Intuitive Surgical: da Vinci Si/Xi Surgical Systems
4 March 2016
Endoscopes, rigid
Model: 380610 / SS3000, 380677 / SS4000, 380652 / PS4000
MHRA reference: 2016/003/007/701/002
KeyMed: Olympus Suction Pump
15 February 2016
Suction equipment
Model: KV-5 Olympus Suction Pump
MHRA reference: 2016/002/026/701/002
Lifetech Scientific: CeraFlex™ Atrial Septal Defect (ASD) Occluder
3 March 2016
Implants, non active, cardiac appendage and septal defect occluders / plugs
Model: L T-ASDf-OS/08/.. /30/32
MHRA reference: 2016/003/004/292/003
Lumenis: Lumenis VersaCut Morcellator
30 July 2015
Surgical instruments, non-articulated cutting
Model: GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P), which includes all products since initial product release
MHRA reference: 2016/003/009/291/001
MAKO Surgical: RESTORIS MCK Tibial Baseplate
25 February 2016
Joint prosthesis, knee
MHRA reference: 2016/002/022/292/001
Orion Pharma: QuikRead go wrCRP, QuikRead go wrCRP+H
3 March 2016
IVDs, clinical chemistry
MHRA reference: 2016/003/001/292/018
Peter Brehm: 60900-66-2 Guiding Rod
R-20151209-1
Surgical instruments, implant
MHRA reference: 2016/003/010/121/001
Siemens Healthcare Diagnostics:Triglycerides_2, Concentrated
March 2016
IVDs, clinical chemistry
Model: Triglycerides_2, Concentrated
MHRA reference: 2016/003/008/601/002
Terumo Corporation: Terumo®ACCUFORCE® PTCA Dilatation Catheter- φ2.5mm
FSCA 1508
Vascular cannula and catheters
Model: DC-RM2512HHW, DC-RM2515HHW, DC-RM2520HHW
MHRA reference: 2016/003/007/701/005
WaveLight:VERION™ Reference Unit
8 March 2016
Optical, ophthalmic instruments & equipment
MHRA reference: 2016/003/008/292/010
Zimmer: Virage OCT Spinal Fixation System
8 March 2016
Spinal Implants
MHRA reference: 2016/003/008/292/005
Zimmer Biomet: RHK Tibial Bearing
4 March 2016
Joint prosthesis, knee
MHRA reference: 2016/003/008/292/011