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.
FDA Recall Z-1023-2025 · Posted 2025-01-27
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Recalling FirmAccuray Incorporated
Recall StatusCompleted
Product CodeIYE
Date Initiated2024-12-23
Product Quantity212
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide - US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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