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 s5x. 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
Enforcement
- Recall Number
- Z-2132-2015
- Event ID
- 71654
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Volcano Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 29, 2015
- Initiation Date
- June 22, 2015
- Classification Date
- July 20, 2015
- Termination Date
- April 14, 2017
- Address
- 2870 Kilgore Rd, N/A, Rancho Cordova, CA, 95670-6133, United States
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 s5x. 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
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Model s5x. Part number: 807300-001.
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
A total of 4007 devices, all models