Recall Z-1023-2025 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
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.
| Date | Jan 27, 2025 (initiated Dec 23, 2024) |
| Status | Completed |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | On December 23, 2024, the firm began notifying customers via Urgent Field Safety Notice letters. Customers were informed that they may continue to use the CyberKnife System clinically, but were reminded to ensure patients are attended when positioning, re-positioning, and leaving the STC. Starting in December, Accuray Customer support will contact customers to schedule service to provide a full inspection and to replace the existing snap rings on the affected retention mechanism of the STC. |
| Quantity | 212 |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170788 | CyberKnife Treatment Delivery System Accuray Incorportaed, Apr 11, 2017 |