Class IIDeviceOngoing

Philips North America Llc

Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.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-3041-2026
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:N/A