Siemens Medical Solutions USA, Inc. has recalled 604 units of Cios Alpha, Cios Flow, and Cios Spin VA30 mobile fluoroscopic C-arm X-ray systems. These medical imaging devices are used in surgical environments but currently contain a software issue and fail to meet updated industry standards for imaging performance. This defect can lead to incorrect medical diagnoses or require patients to undergo repeat radiation exposure. The company has initiated this voluntary recall to address these software requirements and ensure patient safety during surgical procedures.
The software defect may cause the imaging system to provide inaccurate diagnostic data or fail to meet technical standards, leading to misdiagnosis or the need for additional X-ray scans, which increases the patient's total radiation exposure.
Software modification and compliance fulfillment
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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