Brilliance iCT recallZ-3040-2026 · Philips North America Llc · initiated Aug 7, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Radiation Control for Health and Safety Act
What the company is doing
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.
Recall details
- Recall number
- Z-3040-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 7, 2026
- Posted by the FDA
- Sep 1, 2026
- Recalling firm
- Philips North America Llc
- Product code
- JAK
- FDA submissions
- K250648
- Distribution
- US and US Territories.
Product description
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Code information (models, lots, serial numbers)
UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Brilliance iCTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed8 recalls6 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K250648 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Brilliance iCT Brilliance iCT SPPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed1 recall3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99784).
- Z-3042-2026 · Open, ClassifiedPhilips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
- Z-3043-2026 · Open, ClassifiedPhilips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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