Field Safety Notices - 20 March - 24 March 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 20 - 24 March 2017
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
Abbott: NC Trek RX Coronary Dilatation Catheter, NC Traveler RX Coronary Dilation Catheter and NC Tenku RX PTCA Balloon Catheter
22 March 2017
Vascular cannula and catheters
Model: Please see FSN
MHRA reference:
Biomet: Oxford Unicompartmental Cementless Tibial Trays
15 March 2017
Joint prosthesis, knee
MHRA reference:
Cepheid: Xpert庐 CT/NG
07 March 2017
IVDs, bacteriology MHRA reference:
Check-Points: Check-Direct CPE Screen for BD MAX鈩�
25 May 2016
IVDs, bacteriology
MHRA reference:
Curetis: Unyvero BCU Blood Culture Cartridge Set; /#10051 BCU Cartridge Set
13 February 2017
IVDs, bacteriology MHRA reference:
Draeger: Delta/Delta XL/Kappa
March 2017
Monitors, patient
Model: MS18597/MS18596/MS18853
MHRA reference:
Medtronic: DBS Lead Kit for Deep Brain Stimulation
March 2017
Implants, active, leads, neuro
Model:3387, 3389, 3391
MHRA reference:
Philips: Brilliance CT Big Bore
24 February 2017
Computed tomography Model: Brilliance BigBore Oncology CT鈥� 728243, Brilliance BigBore Radiology CT- 728244
MHRA reference:
Smith & Nephew: VERSAJET II Hydrosurgery System Console
21 March 2017
Therapy tissue ablation
MHRA reference:
Tem Innovations: r ex-tem
14 March 2017
Coagulation
MHRA reference:
William Cook: Zenith Alpha鈩� Thoracic Endovascular Graft
March 2017
Implants, non-active, endoprostheses for aortic aneurysms MHRA reference:
Zimmer Biomet: Femoral IM Nail; Segmental Stem; Porous stem
20 March 2017
Osteosynthesis, nails intramedullary MHRA reference:
Zimmer Biomet: Echo庐, Bi-Metric庐 Hip Stem Digital Templates
14 February 2017
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: