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
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