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 FSNs
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: 2017/003/021/291/006
Biomet: Oxford Unicompartmental Cementless Tibial Trays
15 March 2017
Joint prosthesis, knee
MHRA reference: 2017/003/022/701/016
Cepheid: Xpert® CT/NG
07 March 2017
IVDs, bacteriology MHRA reference: 2017/003/017/291/001
Check-Points: Check-Direct CPE Screen for BD MAX™
25 May 2016
IVDs, bacteriology
MHRA reference: 2017/003/020/291/014
Curetis: Unyvero BCU Blood Culture Cartridge Set; /#10051 BCU Cartridge Set
13 February 2017
IVDs, bacteriology MHRA reference: 2017/003/010/291/015
Draeger: Delta/Delta XL/Kappa
March 2017
Monitors, patient
Model: MS18597/MS18596/MS18853
MHRA reference: 2017/003/021/291/007
Medtronic: DBS Lead Kit for Deep Brain Stimulation
March 2017
Implants, active, leads, neuro
Model:3387, 3389, 3391
MHRA reference: 2017/003/020/291/021
Philips: Brilliance CT Big Bore
24 February 2017
Computed tomography Model: Brilliance BigBore Oncology CT– 728243, Brilliance BigBore Radiology CT- 728244
MHRA reference: 2017/003/020/291/016
Smith & Nephew: VERSAJET II Hydrosurgery System Console
21 March 2017
Therapy tissue ablation
MHRA reference: 2017/003/022/701/025
Tem Innovations: r ex-tem
14 March 2017
Coagulation
MHRA reference: 2017/003/020/291/017
William Cook: Zenith Alpha™ Thoracic Endovascular Graft
March 2017
Implants, non-active, endoprostheses for aortic aneurysms MHRA reference: 2017/003/022/701/009
Zimmer Biomet: Femoral IM Nail; Segmental Stem; Porous stem
20 March 2017
Osteosynthesis, nails intramedullary MHRA reference: 2017/003/022/701/010
Zimmer Biomet: Echo®, Bi-Metric® Hip Stem Digital Templates
14 February 2017
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: 2017/003/017/291/002