Philips IQon Spectral CT scanner recalled for potentially loose rotor fasteners
What this means
Philips has identified that fasteners holding the rotor in place inside certain IQon Spectral CT scanners may not be properly tightened. While no equipment failures or injuries have been reported, loose fasteners could theoretically cause rotor parts to become unsecured during operation.
- Check if your facility has one of the 52 affected serial numbers listed in this recall
- Contact Philips if you own an affected unit to arrange inspection and repair
- Do not use the equipment until Philips confirms the fasteners are properly secured
The agency's original wording
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1316-2026More 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-Device2026-09-09Philips 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
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