FDA-Device2026-09-09Class IIPROCESSING DEFECT
Philips Ingenuity CT and related systems recalled for unintended radiation issue
What this means
Philips has identified an unintended radiation issue affecting Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could impact equipment performance. The issue affects specific software versions and product codes distributed in the US and US territories.
- If you operate or maintain one of these CT systems, contact Philips immediately for guidance on the radiation issue and any needed corrective action.
- Do not use affected equipment until you have received instructions from Philips.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US and US Territories.
Affected count
N/A
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3042-2026More Philips recalls
- FDA-Device2026-09-09Philips Brilliance iCT CT scanner recalled for unintended radiation issue
- FDA-Device2026-09-09Philips IQon Spectral CT recalled for unintended radiation issue affecting equipment performance
- FDA-Device2026-09-09Philips Brilliance CT 64 systems recalled for unintended radiation issue
- FDA-Device2026-07-01Philips Telemetry Monitor 5500 recalled for potential device reset and loss of central monitoring connection
- FDA-Device2026-07-01Philips Avalon Fetal Monitor FM 30 recalled for speaker connector assembly defect
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