Philips North America Llc: Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305,
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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 Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
- 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 for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.
- Product quantity
- N/A
- Voluntary mandated
- FDA Mandated
- City
- Cambridge
- State
- MA
- Country
- United States
- Event id
- 99784
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