Moderate riskFDA DeviceSep 9, 2026Class II

Philips Brilliance CT 64 systems recalled for unintended radiation issue

Philips has identified an unintended radiation issue affecting Philips Brilliance CT 64 CT scanner systems (Software 4.1.10.x) that could impact equipment performance. The issue affects multiple Philips CT system models including IQon, iCT, Ingenuity, and Brilliance CT 64.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

If you operate or manage a Philips Brilliance CT 64 system, contact Philips immediately for guidance on the radiation issue and any corrective actions
Do not discard equipment; await instructions from Philips regarding remediation

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Sold in: Nationwide
Made for: All ages

This recall covers 4 products — see all of them.

Details

Units affected: N/A
Illnesses reported: None reported
Manufactured in: 222 Jacobs St, N/A, Cambridge, MA, United States
Classification: Class II
Recall number: Z-3043-2026

In the FDA's words

Description: Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x 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. Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A. Distribution: US and US Territories. Affected quantity: N/A
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.

4 products in this recall

Philips IQon, iCT, Ingenuity and Brilliance CT systems recalled for radiation issue

Philips is recalling four CT scanner product lines, covering 4 product groups, because an unintended radiation issue could affect how the equipment performs. The recall covers Philips Brilliance, IQon Spectral CT, Ingenuity CT, and Brilliance CT 64 systems distributed in the US and US territories. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Z-3040-2026 · N/A
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Z-3041-2026 · N/A
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
Z-3042-2026 · N/A
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x (this page)
Z-3043-2026 · N/A