FDA-Device2026-09-09Class IIPROCESSING DEFECT
Philips Brilliance iCT CT scanner recalled for unintended radiation issue
What this means
Philips has identified an unintended radiation issue affecting Philips Brilliance iCT, Brilliance iCT Upgrades, and Brilliance iCT SP CT scanner systems running software version 4.1.10.x. This issue could affect the performance and safety of the equipment.
- If your facility operates one of these Philips CT models, contact Philips North America immediately for guidance on remediation.
- Do not operate affected equipment until you have received and implemented Philips' corrective instructions.
- Consult the FDA MedWatch alert and your equipment documentation for detailed product codes and UDI numbers.
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. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3040-2026More Philips recalls
- 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-Device2026-09-09Philips 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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