Class IIDeviceOngoing

Philips North America Llc

Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x

Reason for recall

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.

Details

Recall number: Z-3042-2026
Event ID: 99784
Recall initiated: Aug 7, 2026
Classified: Sep 1, 2026
Reported: Sep 9, 2026
Quantity: N/A
Distribution: US and US Territories.
Initiated by: FDA Mandated
Firm notification: N/A
Firm location: Cambridge, MA, United States
Lot / code info: UDI: Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A