FDA-Device2026-09-09Class IIPROCESSING DEFECT
Philips Brilliance CT 64 systems recalled for unintended radiation issue
What this means
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.
- 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
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
All ages
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 Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3043-2026More 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 Ingenuity CT and related 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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