FDA Device recall Z-1740-2025
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x
- FDA Device
- Class II
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class II recall of IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x by Philips Medical Systems Nederland B V, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1740-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-07 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Reason
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.
Identifiers
| code_info | Model Number: 830089; Software Versions: 6x, 7.x, and 8.x; UDI-DIs: (01)00884838106970(11)211130(10)6.1.0.0 (Version 6…Model Number: 830089; Software Versions: 6x, 7.x, and 8.x; UDI-DIs: (01)00884838106970(11)211130(10)6.1.0.0 (Version 6.1.0.0), (01)00884838106970(11)220623(10)6.2.0.0 (Version 6.2.0.0), (01)00884838115378(11)221214(10)7.0.0.0 (Version 7.0.0.0), (01)00884838115378(11)230711(10)7.1.0.0 (Version 7.1.0.0), (01)00884838122000(11)240325(10)8.0.0.0 (Version 8.0.0.0). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1740-2025%22
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