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
FDA Recall Z-2131-2015 · Posted 2015-07-20
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Recalling FirmVolcano Corporation
Recall StatusTerminated
Product CodeIYO
Date Initiated2015-06-22
Date Terminated2017-04-14
Product QuantityTotal of 4007 devices, all models
Reason for Recall
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Firm Action
Urgent Medical Device Correction letters were sent on June 22, 2015 to all affected sites via FED Ex.
Root Cause
Software design
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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