Class 2 Device Recall Accuray Cyberknife

• Date Initiated by Firm: June 16, 2026
• Date Posted: July 01, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2640-2026
• Recall Event ID: 99075
• 510(K)Number: K170788
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
• Code Information: All systems prior with software version 11X that utilize the Exchange Table
• FEI Number: 3003873069
• Recalling Firm/ Manufacturer: Accuray Incorporated; 1240 Deming Way; Madison WI 53717-1954
• For Additional Information Contact: 608-824-2800
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software design
• Action: Accuray issued am Urgent Field Safety Notice to it consignees via hand delivered letter on 6/16/2026. The notice explained the issue, potential 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 instruments. For questions, please contact Accuray Customer Support by phone or email, using the Service Request form available at http://www.accuray.com/service-requests.
• Quantity in Commerce: 48 units
• Distribution: Worldwide distribution - US Nationwide and the countries of China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Republic of, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, Ukraine.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYE