Volcano s5 — Class II medical device recall Z-1813-2016
Terminated recall by Volcano Corporation, reported 2016-06-01, distributed nationwide. Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In s
| Recall number | Z-1813-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2016-04-25 |
| Classified | 2016-05-25 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2018-01-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CL, CN, CR, CY, CZ, DE, DK, DO, DZ, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IQ, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, PY, RO, SA, SE, SG, SK, TH, TN, TR, TW, VE, ZA |
| UPC / GTIN / UDI-DI | 00101950045001, 00101950285001, 00101950579001, 00101950678001, 00101950780001, 00101951051001, 00101951288001, 00101951303001, 00102120270001, 00102120308001, 00102120618001, 00102121020001, 00102121033001 |
| Serial numbers | 05028, 05036, 05205021001, 05206001001, 05206042001, 05206046001, 05206115001, 05206188001, 05206363001, 0520641200, 05206734001, 05206884001, 05207007001, 05207035001, 05207131001, 05208168001, 05208457001, 05208721001, 05320041001, 05339, 05627, 05660, 06801062001, 06802011001, 06804119001 and 21 more |
Product
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging 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
Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot
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-1813-2016. 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.