IntelliSpace Cardiovascular software versions 6 — Class II medical device recall Z-1740-2025
Ongoing recall by Philips Medical Systems Nederland B.V., reported 2025-05-14, distributed nationwide. An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing
| Recall number | Z-1740-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems Nederland B.V., Eindhoven, N/A, Netherlands |
| Recall initiated | 2025-04-07 |
| Classified | 2025-05-08 |
| Reported by FDA | 2025-05-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, DK, EE, ES, FI, FR, GB, GR, HK, ID, IE, IT, JP, LU, MX, NL, NO, PL, SA, SE, TH, ZA |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838106970, 00884838115378, 00884838122000 |
| Model numbers | 830089 |
Product
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Reason for recall
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
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-1740-2025. 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.