Philips Volcano FFR software used in the following systems connected… — Class II medical device recall Z-0674-2020
Terminated recall by Volcano Corporation, reported 2019-12-18, distributed nationwide. Interoperability issue that affects certain systems that use the recalled software when it is connected to spe
| Recall number | Z-0674-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2018-11-07 |
| Classified | 2019-12-12 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2022-07-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CR, CY, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IS, IT, JO, JP, KR, LB, LT, MT, MX, MY, NL, NO, NZ, PK, PL, PT, RO, RS, SA, SE, SG, SI, SK, TR, TW, ZA |
| Quantity | 3,667 units |
| Reason classes | software |
| Model numbers | 0100.02, 400, 400-0100.01, 400-0100.01-R, 400-0100.02, 400-0100.07, 400-0100.07-R, 400-0100.08, 400-0100.08-R, 4536-010-52781, 4536-010-57091, 5322466, 804200001R, 806300003, 807300001, 807400001, 807400001R, 807401200 |
Product
Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System, Part#806300003; (4) s5i Imaging System, Part#5322466; (5) s5x Imaging System, Part#807300001; (6) s5x Imaging System Refurbished, Pat#807300001 R; (7) s5 Imaging System Refurbished, Part#804200001 R; (8) CORE Mobile Imaging System (120V), Part #400-0100.01; (9) CORE Mobile Imaging System Refurbished, Part #400-0100.01-R; (10) CORE Mobile Imaging System (240V), Part #400-0100.07; (11) CORE Mobile Imaging System Refurbished, Part #400-0100.07-R; (12) CORE Mobile Imaging System (100V), Part #400-0100.08; (13) CORE Mobile Imaging System Refurbished, Part #400-0100.08-R; and (14) CORE Imaging System, Part #400-0100.02; (15) CORE Integrated Imaging System Refurbished, Part#400 0100.02 R.
Reason for recall
Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
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-0674-2020. 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.