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Philips North America Llc: Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. S

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

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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 Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.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: Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A
Product quantity
N/A
Voluntary mandated
FDA Mandated
City
Cambridge
State
MA
Country
United States
Event id
99784
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