Philips North America Llc is recalling 385 CT scanning systems, including Brilliance iCT, IQon Spectral CT, and Spectral CT models, because fasteners used to attach the rotor inside the machine may not be tightened correctly. If these fasteners fail, parts of the rotor could become loose or be expelled while the machine is spinning. This issue affects units distributed worldwide and across 24 U.S. states. The company is contacting affected facilities to arrange for a technician to inspect and correctly torque the fasteners to prevent equipment failure.
If multiple fasteners are not torqued to specification, the heavy internal rotor or its parts may become unsecured or displaced during high-speed rotation. While no parts have been expelled to date, such an event could cause significant damage to the medical device and poses a potential safety risk to patients or staff in the vicinity.
Recall #: Z-1315-2026
Recall #: Z-1316-2026
Recall #: Z-1317-2026
Recall #: Z-1318-2026
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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