Accuray Incorporated: Cyberknife Treatment Deliver System Equipped With The Xchange Robotic Collimator Changer; Linear Accelerator
Cyberknife Treatment Delivery System Recall Summary Accuray is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a safety issue where a collimator may not fully dock properly, and if operators use the in-room control pendant after this happens, the collimator can fall from its housing. This recall affects medical facilities worldwide, including all U.S. states, as well as facilities in China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, and Ukraine.
- Recalling firm
- Accuray Incorporated
- Product
- Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-16
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/418632e3-d41e-4e7f-95d7-a3ed5dd30b09