Field Safety Notices - 16 January - 20 January 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 16 - 20 January 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

Aesculap: LEKTRAFUSE HF Generator Bipolar

6 December 2016

Surgical, diathermy

Model: GN200

MHRA reference: 2016/012/007/701/011

Alba Bioscience: ALBAclone Advanced Partial RhD Typing Kit

14 October 2016

IVDs, blood transfusion

Model: Z293

MHRA reference: 2016/010/014/601/002

Bard Medical Division: Multi-length ureteral stents

17 January 2017

Implants, non-active, non-vascular stents

MHRA reference: 2017/001/017/601/009

bioMérieux: NucliSENS ® easyMAG ® Magnetic Silica

12 January 2017

IVDs, viral microbiology

MHRA reference: 2017/001/013/299/004

bioMérieux: VIDAS ® 3, VIDAS LYME IgG

13 January 2016

IVDs, viral microbiology

MHRA reference: 2017/001/017/299/023

Biomet:Accu-Cut Saw Blade AO Drive

16 January 2017

Surgical power tools

MHRA reference: 2017/001/018/291/002

Cardiac Pacemaker: EMBLEM™ S-ICD Programmer

12 January 2017

Implants, active, defibrillators

Model: 3200

MHRA reference: 2017/001/010/299/013

Carestream Health: DRX-Revolution Mobile X-Ray System

13 January 2017

X-ray, mobiles

Model: Mobile System

MHRA reference: 2017/001/019/291/018

Gynesonics: Sonata Radiofrequency Ablation

FSCA-1601

Surgical, diathermy

Model: SA 03605

MHRA reference: 2016/012/030/601/004

Handicare: Carina350EM

22 December 2016

Hoists and slings

MHRA reference: 2016/005/025/299/001

Küschall: Manual wheelchairs

20 January 2017

Wheelchairs, manual

Model: KSL K-Series K-Series attract R33 Advance Champion, Compact attract Ultralight

MHRA reference: 2017/001/017/701/029

Ossur: Various

012016

Orthoses

MHRA reference: 2017/001/012/701/019

Siemens: INNOVANCE D-Dimer

January 2017

Coagulation

MHRA reference: 2017/001/012/701/014

Siemens: ADVIA Centaur Systems Calibrator A

11 January 2017

Instrumentation/ platform

MHRA reference: 2017/001/016/601/004

Van Oostveen: Romed 2-part syringes, 20 ml

5 January 2017

Injection devices

Model: SYR-20ML

MHRA reference: 2017/001/005/701/018

Vigmed: SWiTCH, Needle protected safety catheter

10 January 2017

Vascular cannula and catheters

MHRA reference: 2017/001/016/299/001

Zimmer: Revitan ® Revision Stem System

12 January 2017

Joint prosthesis, hip

MHRA reference: 2017/001/016/701/023

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