IntelliSpace Cardiovascular, Software 8.0.0.4.
Recall
- Recall Number
- Z-2543-2025
- Event Number
- 97379
- Firm
- Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands
- FEI Number
- 3000976525
- Product Code
- LLZ
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- August 8, 2025
- Posted
- September 9, 2025
Description
IntelliSpace Cardiovascular, Software 8.0.0.4.
Software issue that results in the display of outdated information.
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 [email protected]. 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).
US Nationwide distribution in the states of GA, NC & TX.
4 units