IntelliSpace Cardiovascular, Software 8.0.0.4.
FDA device recall Z-2543-2025 · posted 2025-09-09 · Open, Classified
Recall details
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Reason for recall
- Software issue that results in the display of outdated information.
- Action taken
- An URGENT Medical Device Correction notice dated 8/7/25 was mailed to consignees. The notification includes instructions for continued safe use of devices, which includes: 1. Ensure all finding codes with variables/modifiers are populated correctly on the report screen. Do not leave any FitB Modifier Code Fields Blank. 2. Verify report statements match the selections in the work area before finalizing report. Systems may continue to be used in accordance with the intended use and per the additional instructions. The provided recall notification is to be shared with all users of the device and retained with affected systems until the corrected software is installed. The provided recall response form should be returned within 30 days to Philips.recall@Philips.com. A Philips representative will call consignees to schedule a time to install the software solution (FCO83000218). Consignees with any questions can contact Philips Informatics Customer Support at 1-800-996-1328 (x1).
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 4 units
- Distribution
- US Nationwide distribution in the states of GA, NC & TX.
- Date initiated
- 2025-08-08
- Date posted
- 2025-09-09
- Location
- Eindhoven, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Philips IntelliSpace Cardiovascular (K153022) | Philips Medical Systems Nethrlands BV | 2015-11-18 |