Volcano Imaging System s5i REF 807400001 — Class II medical device recall Z-0189-2018
Terminated recall by Volcano Corporation, reported 2017-12-06, distributed nationwide. On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the us
| Recall number | Z-0189-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2017-11-03 |
| Classified | 2017-11-29 |
| Reported by FDA | 2017-12-06 |
| Terminated | 2023-10-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, GB, LK |
| Quantity | 1,166 units |
| UPC / GTIN / UDI-DI | 00102120086268, 00102120086527, 00102120086848, 00102120088873, 00102120093839, 00102160289001, 00102170006001, 00103020083296, 00103020083838, 00103020083852, 00103020084132, 00103020084248, 00103020084446, 00103020084521, 00103020084668, 00103020085108, 00103020085849, 00103020086037, 00103020086808, 00103020087140, 00103020087263, 00103020087966, 00103020088345, 00103020088819, 00103020089298 and 87 more |
| Serial numbers | 06802235001, 06804339001, 06804395001, 102120012001, 102120085138, 102120085140, 102120085691, 102120085748, 102120085749, 102120085839, 102120085840, 102120086108, 102120086178, 102120086268, 102120086269, 102120086495, 102120086525, 102120086527, 102120086528, 102120086530, 102120086759, 102120086845, 102120086846, 102120086847, 102120086848 and 475 more |
| Model numbers | 400-0100.01, 400-0100.01-R, 400-0100.02, 400-0100.07, 400-0100.07-R, 400-0100.08, 400-0100.08-R, 807400001 |
Product
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished REF 400-0100.08-R; CORE Imaging System REF 400-0100.02 For intravascular ultrasound imaging.
Reason for recall
On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device.
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-0189-2018. 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.