Recall Z-3040-2026
Philips North America Llc · initiated August 7, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Codes / lots: UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.
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.
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
Philips will inform customers of the issue via an Electronic Product Radiation Correction notification, dated "AUG 2026". Philips will schedule an appointment with remaining customers to update the software free of charge. Customers who need additional information or support concerning this issue should be directed to their local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). Philips reference: 2025-PD-CTAMI-014.
Details
- Recall number
- Z-3040-2026
- Initiated
- August 7, 2026
- Posted by FDA
- September 1, 2026
- Product code
- JAK – System, X-Ray, Tomography, Computed
- Distribution
- US and US Territories.
- Recalling firm
- Philips North America Llc, Cambridge, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3041-2026 Class II | Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331…Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance… | 08/07/2026Open, Classified |
| Z-3042-2026 Class II | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China…Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance… | 08/07/2026Open, Classified |
| Z-3043-2026 Class II | Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT…Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance… | 08/07/2026Open, Classified |