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
Reported: July 29, 2015 Initiated: June 22, 2015 #Z-2133-2015
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.
Details
- Recalling Firm
- Volcano Corporation
- Units Affected
- A 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
- Location
- Rancho Cordova, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Volcano Corporation. Units affected: A total of 4007 devices, all models.
Why was this product recalled? ▼
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2015. Severity: Moderate. Recall number: Z-2133-2015.
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