Field Safety Notices: 19 to 23 July 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 19 to 23 July 2021.
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
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View . FSNs before this date are on the
EKF Diagnostics Holdings: Beta-hydroxybutyrate Liquicolor
12 July 2021
IVDs, clinical chemistry
Model: Beta-hydroxybutyrate Liquicolor
MHRA reference:
Emergo Europe: BIB/Orbera/Orbera365 Intragastric Balloon Systems
01 July 2021
Implants, non active, gastrointestinal
Model: B-40800, B-50000, B-50012
MHRA reference:
Getinge Cardiopulmonary: Tubing Set
23 July 2021
Infusion & transfusion, heart lung circuits
MHRA reference:
GORE & Associates: Molding and Occlusion Balloon Catheter
July 2021
Vascular cannula and catheters
Model: MOB37
MHRA reference:
Medtronic: Activa Clinician Programmer Application Phase 2 - software update
July 2021/FA968 & FA969
Implantable neuro stimulators
Model: A610
MHRA reference:
Medtronic: Endurant II, IIs Stent Graft System Radiopaque Marker Detachment
June 2021/FA982
Implants, non active, endoprostheses for aortic aneurysms
Model: ETUF3214C102EE, ETBF3216C166EE, ESBF3614C103EE, ETCF3636C49EE
MHRA reference:
Medtronic: HeartWare Ventricular Assist System 鈥� Phase II (HVAD)
July 2021/FA981 Phase II
Implantable ventricular assist devices
Model: 1104
MHRA reference:
Medtronic: Pipeline Flex Embolization Device,
Pipeline Flex Embolization Device with Shield Technology
July 2021/FA985
Intracranial flow diverters / stents
MHRA reference:
Olympus: SOLTIVE PREMIUM LASER & SOLTIVE PRO LASER
July 2021/QIL 154-006
Therapy, lasers
Model: Premium EGTFL-PLS & Pro EGTFL-SLS
MHRA reference:
Olympus: GASTROINTESTINAL VIDEOSCOPE & COLONOVIDEOSCOPE
July 2021/QIL 154-007
Endoscopes, flexible
Model: GIF-EZ1500 & CF-EZ1500DL, CF-EZ1500DI & CV-1500 (虏*EVIS X1 Video SYSTEM Center CV-1500)
MHRA reference:
Smith & Nephew: Birmingham Hip Square Headed Nail
4 July 2021
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference:
Teleflex Medical: Slick Set, Flexi-Set, RUSCHELIT Safety Clear Plus, RUSCHELIT Super Safety Clear, Super Safety Clear Flexiset, Endotracheal Tube with Cuff/Murphy, Endotracheal Tube Magill, Endo Tracheal Tube Murphy Eye
July 2021/EIF-000464_EIF-000479
Airway devices
Model: Various
MHRA reference: