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

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