FDA-Device2026-09-09Class IIPROCESSING DEFECT
Philips IQon Spectral CT recalled for unintended radiation issue affecting equipment performance
What this means
Philips has identified an unintended radiation issue affecting the IQon Spectral CT and related CT systems (iCT, Ingenuity, and Brilliance CT 64 models). This issue could affect the performance of the equipment. The problem was found in software version 4.7.7.x.
- Contact Philips if you operate or maintain one of these CT systems
- Check for any corrective instructions or software updates 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 IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3041-2026More Philips recalls
- FDA-Device2026-09-09Philips Brilliance iCT CT scanner recalled for unintended radiation issue
- 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.