Accuray Incorporated — Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 16, 2026
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.
What's affected?
- Product
- Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
- Brand
- Accuray Incorporated
- Lot code
- All systems prior with software version 11X that utilize the Exchange Table
Additional details
All systems prior with software version 11X that utilize the Exchange Table
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 48 units.
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