FDA Device recall Z-2543-2025
IntelliSpace Cardiovascular, Software 8.0.0.4
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of IntelliSpace Cardiovascular, Software 8.0.0.4 by Philips Medical Systems Nederland B V, citing software issue that results in the display of outdated information.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2543-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-08 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
IntelliSpace Cardiovascular, Software 8.0.0.4.
Reason
Software issue that results in the display of outdated information.
Identifiers
| code_info | Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193. |
|---|
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-2543-2025%22
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