Z-2133-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2015
- Initiation Date
- June 22, 2015
- Termination Date
- April 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- A total of 4007 devices, all models
Product Description
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 CORE Mobile. 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
Reason for Recall
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Distribution Pattern
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
Code Information
Model CORE Mobile. Part number: 400-0100.01.