Volcano s5/s5i/CORE Intravascular Ultrasound Systems software… — Class II medical device recall Z-2133-2015
Terminated recall by Volcano Corporation, reported 2015-07-29, distributed nationwide. A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstan
| Recall number | Z-2133-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2015-06-22 |
| Classified | 2015-07-20 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2017-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BO, BR, CA, CL, CR, DO, DZ, EG, HK, IL, IN, IR, JO, JP, KE, KR, KW, LB, MX, MY, NZ, PH, SG, SV, TH, TW, ZA |
| Quantity | 4,007 devices |
| Reason classes | software |
| Model numbers | 400-0100.01 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2133-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.