Posts Tagged ‘Focus Dianostics’

Säljstopp – Medicintekniska produkter

söndag, augusti 7th, 2016

I det europeiska vigilance-systemet är det respektive lands CA,  Competent Authority, som registrerar säkerhetsmeddelanden och genomför återkallanden av medicintekniska produkter från marknaden. I Sverige Läkemedelsverket. På den amerikanska marknaden ansvarar och beslutar FDA, Food and Drug Administration, om recalls.

Nedan hittar du FDAs lista över medicintekniska produkter som har falerat och dragits tillbaka från marknaden hittills under 2016. De medicintekniska företag som finns fler gånger på listan är Dräger, Stryker och Cook Medical.

Dräger Recalls VentStar Oxylog 3000 Pediatric Patient Breathing Circuit Due to Potential Valve Leakage

CareFusion Recalls AVEA Ventilator Due to an Electrical Issue Which May Cause an Unexpected Shutdown
Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) Recalls Flush Angiographic Catheter Due to Tip Separation
HeartWare Inc. Extends Recall to Include Batteries Used in the Ventricular Assist Device Due to Premature Power Depletion
Medtronic Respiratory and Monitoring Solutions Recalls Battery Pack Used on Patient Monitors Due to Potential Fire Risk
Hummingbird Med Devices Inc. Recalls Hummi Micro-Draw Blood Transfer Device Due to Potential for Parts to Disconnect
B. Braun Medical Inc. Recalls Dialog+ Hemodialysis Systems Due Defective Conductivity Sensors
Boston Scientific Corporation Recalls Fetch 2 Aspiration Catheter Due to Shaft Breakage
Vascular Solutions Recalls Guardian II Hemostasis Valve Due to Low Pressure Seal Defect
Focus Diagnostics Recalls Laboratory Examination Kits Due to Inaccurate Test Results
Dexcom Inc. Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers Due to Audible Alarm Failure
Cook Medical Recalls Central Venous Catheter and Pressure Monitoring Sets and Trays due to Tips that May Split or Separate
Verathon Inc. Recalls GlideScope Titanium Single-Use Video Laryngoscope Due to Potential Video Feed Disruption
Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue
Abbott Vascular Recalls MitraClip Clip Delivery System Due to Issue with Delivery System Deployment Process
Dräger Evita V500 and Babylog VN500 Ventilators – Recall Expanded to Include Optional PS500 Batteries with New Power Supply Firmware
Cook Medical Expands Recall for Beacon Tip Angiographic Catheters to Include Additional Product Lots
Dräger Medical Inc. Recalls Emergency Transport Ventilators Due to a System Error that may lead to a Halt in Ventilation Therapy
Arkray Recalls SPOTCHEM II Test Strips Due to Inaccurate Blood Sugar Readings
Thornhill Research Inc. Recalls MOVES Ventilator System Due to Battery Problem
St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads Due to Damage that May Prevent Patient Therapy
Brainlab Cranial Image-Guided Surgery (IGS) System – Navigation Inaccuracy
Stryker Fuhrman Pleural and Pneumopericardial Drainage Sets – Catheter May Break During Insertion
Dräger Evita V500 and Babylog VN500 Ventilators – Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly