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Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x

Class II
Recalling firm
Philips North America Llc
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.
Affected products (lot / model / serial)
UDI:N/A
Units affected
N/A
Distribution pattern
US and US Territories.
Firm location
Cambridge, MA, United States
Recall type
FDA Mandated
How the firm notified customers
N/A
Product type
Devices
Status
Ongoing
Recall number
Z-3041-2026
Recall initiated
August 7, 2026
FDA classification date
September 1, 2026
FDA report date
September 9, 2026
FDA event ID
99784
Last updated on HTM Vibe
September 15, 2026
View on openFDA