Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and… — Class II medical device recall Z-2044-2015
Terminated recall by Volcano Corp, reported 2015-07-15, distributed nationwide. A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS
| Recall number | Z-2044-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corp, San Diego, CA, United States |
| Recall initiated | 2013-09-23 |
| Classified | 2015-07-08 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2015-07-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, DK, FR, GB, IS, NL, PH, SA, SE, TH |
| Quantity | 227 units |
| Model numbers | 806300-020, S5I |
Product
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
Reason for recall
A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
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-2044-2015. 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.