Accuray Incorporated recalls Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

Accuray issued an Urgent Field Safety Notice to its consignees via hand delivered letter on 6/16/2026. The notice explained the issue, risk to health, and provided the following safety instructions: "This condition may occur during collimator housing drop off or pick up while the collimator housing is positioned over the Xchange table. The system will interlock, stop motion, and display a message at the operator console to contact service. If an interlock occurs: (1) remove the patient from the treatment room before troubleshooting, (2) do not initiate treatment robot motion from the in-room control pendant, and (3) contact Accuray Service to safely release the collimator housing." Accuray is correcting the units. For questions, please contact Accuray Customer Support by phone or email, using the Service Request form available at http://www.accuray.com/service-requests.

• FDA enforcement recordOfficial FDA database entry for Z-2644-2026
• 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.