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FDAFDA · Food and drugs·Recall number Z-3040-2026

Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.

Published September 9, 2026 · Recall initiated: August 7, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

FDA Mandated

Recall details

Manufacturer
Philips North America Llc
Distributor
US and US Territories.
Lot
UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.
Risk classification
Class II
Area (FDA)
device
Country
United States

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