Philips Medical Systems Nederland B.V. recalls Philips IntelliSpace Cardiovascular software

Study data is not able to be archived, copied, or exported with the cardiovascular software version.

Philips IntelliSpace Cardiovascular software, Model 830089.

The recalling firm initially issued an "Important Product Notice" dated 3/12/2024 which their consignees received on 4/4/2024 informing them that Philips had identified an issue with the IntelliSpace Cardiovascular software version 7.0 where study data is not able to be archived, copied, or exported. The notice was to explain the issue and under what circumstances it can occur, the affected products and how to identify them, the actions the customer can take to minimize the effect of the issue, and the actions planned by Philips to correct the issue. The actions were: (1) The customer may continue to use the system in accordance with its intended use; (2) If study data cannot be archived, exported, or copied from ISCV via DICOM or to a CD, update the "Reason for Study" field using less than 64 characters; (3) Circulate the notice to all users of the system so they are aware of the issue; and (4) Retain the letter with the system until Philips has implemented the software correction. Philips will contact the customer to schedule a time for a Field Service Engineer to visit their site and install a software solution to resolve the issue. No response form was enclosed. A follow-up Urgent Medical Device Correction letter dated 1/8/2025 was issued on 1/10/2025 to the U.S. consignees who have not yet received the software correction. The letter supersedes the initial 3/12/2024 letter. The 1/8/2025 letter contains updated information with respect to the potential hazard/harm associated with the issue based on the revised Health Hazard Evaluation (HHE Rev C, 02-Jan-2025). The letter also had a response form attached for completion and return no later than 30 days after receipt of the letter.

• FDA enforcement recordOfficial FDA database entry for Z-1252-2025
• 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.