Drug recall
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
FDA recall event 96377 · Class II · Philips Medical Systems Nederland B.V.
Key facts
| Event ID | 96377 |
|---|---|
| Recall numbers | Z-1740-2025 |
| Recalling firm | Philips Medical Systems Nederland B.V. |
| Product type | Devices |
| Products | IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Apr 7, 2025 |
| Report date | May 14, 2025 |
| City | Eindhoven |
| Country | Netherlands |
| FEI number | 3000976525 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: