Accuray Incorporated
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Accuray Incorporated and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-02-05FDA-DeviceClass IICyberKnife 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.
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.
- 2023-09-06FDA-DeviceClass IIUpper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.
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