FDA Device recall Z-1252-2025
Philips IntelliSpace Cardiovascular software, Model 830089
- FDA Device
- Class II
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class II recall of Philips IntelliSpace Cardiovascular software, Model 830089 by Philips Medical Systems Nederland B V, citing study data is not able to be archived, copied, or exported with the cardiovascular software version.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1252-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-04 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Philips IntelliSpace Cardiovascular software, Model 830089.
Reason
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Identifiers
| code_info | Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0. |
|---|
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-1252-2025%22
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