Accuray Incorporated has recalled 212 CyberKnife Treatment Delivery Systems, including those labeled as CyberKnife M6 and VSI Robotic Surgery Systems. The recall was initiated because snap rings within the internal mechanism may detach or become damaged, which could lead to uncontrolled robotic rotation during medical procedures. Healthcare facilities should stop using the affected systems and contact the manufacturer or their authorized distributor to arrange for a necessary mechanical correction.
Detached or damaged snap rings can cause the system to lose control of its rotation on the left and right roll axes. This mechanical failure poses a high risk of injury to patients undergoing image-guided stereotactic radiosurgery or radiotherapy treatments.
Indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.