Accuray Incorporated: Device Recall
Recall #Z-1023-2025 · 12/23/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1023-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Accuray Incorporated
- Status
- Completed
- Date Initiated
- 12/23/2024
- Location
- Madison, WI, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 212
Reason for Recall
Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
Product Description
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Distribution Pattern
Worldwide - US Nationwide distribution.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.