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U.S. Department of Health and Human Services

Class 2 Device Recall Accuray Cyberknife

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 Class 2 Device Recall Accuray Cyberknifesee related information
Date Initiated by FirmJune 16, 2026
Date PostedJuly 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2644-2026
Recall Event ID 99083
510(K)NumberK170788 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductCyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Code Information ALL Cyberknife systems running software version 11.X and higher 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 2		Software design
ActionAccuray 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.
Quantity in Commerce292 units
DistributionWorldwide - US Nationwide and and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kenya, Korea, Republic of, Liechtenstein, Lithuania, Luxembourg, Macao, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYE
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