Field Safety Notice - 17 to 21 July 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 July 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
Alere: Alere HIV Combo
14 July 2017
IVDs, viral microbiology
MHRA reference: 2017/007/017/291/028
Exactech: 3.2mm Vix Bit
11 July 2017
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference: 2017/007/017/291/057
Hitachi High Technologies: Cobas 6000, Cobas 8000
11 July 2017
IVDs, clinical chemistry
Model: cobas 6000 system cobas c501 module, model number: 04745914001
cobas 8000 modular analyzer cobas c502 module, model number: 05964067001
Acessories/spare part: Ultrasonic Mixer Cover (USM cover 3), catalogue number 05400937001
MHRA reference: 2017/007/013/701/002
Immucor GTI Diagnostics: LIFECODES HLA-DPA1/B1 SSO Typing Kit
07 July 2018
IVDs, immunology
MHRA reference: 2017/007/017/291/026
Lombard Medical: Altura Endograft System
30 June 2017
Implants, non-active, endoprostheses for aortic aneurysms
Model: 01-AA-24-090
MHRA reference: 2017/007/003/291/035
Medtronic: Euphora Rapid Exchange Balloon Dilatation Catheter / Solarice Rapid Exchange Balloon
Dilatation Catheter
13 July 2017
Vascular cannula and catheters
Model: Various, see customer letter
MHRA reference: 2017/007/014/291/012
Ortho-Clinical: ORTHO BioVue System (Rh/K Cassette)
13 July 2017
IVDs, blood transfusion
MHRA reference: 2017/007/017/601/002
Össur: Rebound Foot-Up
July 2017
Orthoses
Model: RFU50001, RFU500011, RFU50002, RFU500021
MHRA reference: 2017/007/018/291/005
Shippert Medical Technologies: Tissu-Trans
12 June 2017
Surgical instruments, minimal access
Model: Tissu-Trans Filtron 100, Tissu-Trans Filtron 500, Tissu-Trans
MHRA reference: 2017/006/030/291/037
Smith and Nephew: ENACT SEPTAL STAPLER 3-PACK
7 June 2017
Staples and staple guns
MHRA reference: 2017/007/013/291/006
Terumo: Terumo OPS Valve
17 July 2017
Infusion & transfusion, connectors
Model: OPS valve sterile, OPS valve non-sterile
MHRA reference: 2017/007/017/701/022
Toshiba: Radrex-i DRAD-3000E/W8
17 July 2017
X ray, digital acquisition systems
Model: Radrex-i DRAD-3000E/W8
MHRA reference: 2017/007/018/291/010
Zimmer Biomet: Persona Partial Knee Guide Size 8
14 July 2017
Orthopaedic surgical instruments - measuring tools
MHRA reference: 2017/007/017/291/009