Official recall notice

FDA DeviceClass IINotable

FDA Recall: Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Softwa

Recall date
2026-09-09
FDA class
Class II

Why it was recalled

Hazard

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.

Product description

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

UDI:N/A

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