Recall Z-2131-2015
Volcano Corporation · initiated June 22, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. 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
Codes / lots: Model s5. Part numbers: 804200-002 and 804200-014
Reason for recall
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
FDA-determined cause: Software design
Action taken
Urgent Medical Device Correction letters were sent on June 22, 2015 to all affected sites via FED Ex.
Details
- Recall number
- Z-2131-2015
- Initiated
- June 22, 2015
- Posted by FDA
- July 20, 2015
- Terminated
- April 14, 2017
- Product code
- IYO – System, Imaging, Pulsed Echo, Ultrasonic
- Quantity
- Total of 4007 devices, all models
- Distribution
- 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
- Recalling firm
- Volcano Corporation, Rancho Cordova, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2132-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | 06/22/2015Terminated |
| Z-2133-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | 06/22/2015Terminated |
| Z-2134-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | 06/22/2015Terminated |
| Z-2135-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | 06/22/2015Terminated |
| Z-2136-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | 06/22/2015Terminated |