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

Medical DevicesSource: FDA (device) · Date: 2026-09-09

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips North America Llc
Product
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US and US Territories.
Recall initiated
2026-08-07
Code info
UDI:N/A
Product quantity
N/A
Voluntary mandated
FDA Mandated
City
Cambridge
State
MA
Country
United States
Event id
99784
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