- Recalling firm
- Philips North America Llc
- Reason for recall
- 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 (lot / model / serial)
- UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.
- Units affected
- N/A
- Distribution pattern
- US and US Territories.
- Firm location
- Cambridge, MA, United States
- Recall type
- FDA Mandated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3040-2026
- Recall initiated
- August 7, 2026
- FDA classification date
- September 1, 2026
- FDA report date
- September 9, 2026
- FDA event ID
- 99784
- Last updated on HTM Vibe
- September 15, 2026