IntelliSpace Cardiovascular, Software 8.0.0.4.
This recall is currently active, issued September 9, 2025. It was issued by Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands.
- Recall Initiated
- August 8, 2025
- Posted
- September 9, 2025
- Recall Number
- Z-2543-2025
- Quantity
- 4 units
- Official Source
- View on FDA website ↗
Reason for Recall
Software issue that results in the display of outdated information.
Distribution
US Nationwide distribution in the states of GA, NC & TX.
Lot / Code Info
Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
Root Cause
Software design
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).