Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall (Accuray Incorporated)
Medical deviceClass IIOngoing
Summary: Accuray Incorporated is recalling 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.
What is being recalled
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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.
How to tell if yours is affected
All systems prior with software version 11X that utilize the Exchange Table
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2640-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 16, 2026 |
| Reported | July 8, 2026 |
| Company | Accuray Incorporated |
| Company location | Madison, WI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 48 units |
More recalls from Accuray Incorporated · all medical device recalls · recalls from June 2026