Philips North America LLC recalls Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

Philips will inform customers of the issue via an Electronic Product Radiation Correction notification, dated "AUG 2026". Philips will schedule an appointment with remaining customers to update the software free of charge. Customers who need additional information or support concerning this issue should be directed to their local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). Philips reference: 2025-PD-CTAMI-014.

• FDA enforcement recordOfficial FDA database entry for Z-3042-2026
• FDA 510(k) clearance · K160743The device's official FDA premarket clearance record
• FDA device classification · JAKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips North America LlcSearch 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.