Accuray Incorporated recalls CyberKnife Treatment Delivery System

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1023-2025
• FDA 510(k) clearance · K170788The device's official FDA premarket clearance record
• FDA device classification · IYEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Accuray IncorporatedSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.