Siemens Medical Solutions USA, Inc. is recalling 97 units of its SOMATOM X.ceed and NAEOTOM Alpha series CT scanning systems because they contain specific software applications that have not received the required FDA 510(k) clearance. These applications include tools for brain quantification, vessel hyperdensities, and ASPECTS scoring. Siemens is initiating this voluntary recall to remove the unauthorized software from the affected medical devices, which were distributed across the United States and internationally.
The use of medical software applications that have not been cleared by the FDA means their safety and effectiveness have not been formally reviewed, which could potentially lead to inaccurate diagnostic information for patients undergoing CT scans.
Recall #: Z-1239-2026
Recall #: Z-1240-2026
Recall #: Z-1241-2026
Recall #: Z-1242-2026
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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