Class IIDeviceOngoing

Philips North America Llc

Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.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-3043-2026
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: Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.