Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular

Software issue that results in the display of outdated information.

IntelliSpace Cardiovascular, Software 8.0.0.4.

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).

• FDA enforcement recordOfficial FDA database entry for Z-2543-2025
• FDA 510(k) clearance · K153022The device's official FDA premarket clearance record
• FDA device classification · LLZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips Medical Systems Nederland B.V.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.