FDAFDA · Food and drugs·Recall number Z-2134-2015
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature
Published July 29, 2015 · Recall initiated: June 22, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Volcano Corporation
- Distributor
- Worldwide Distribution-US (nationwide) and regions in Europe and the countries of Japan, Canada, South Africa, Taiwan, Thailand, Singapore, Philippines, Australia, New Zealand, El Salvador, Malaysia, Mexico, Lebanon, Kuwait, South Korea, Kenya, Jordan, Iran, India, Israel, Hong Kong, Egypt, Algeria, Dominican Republic, Costa Rica, Chile, Brazil, Bolivia, and Argentina
- Lot
- Model s5i. Part number: 806300-020.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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