FDAFDA · Food and drugs·Recall number Z-2640-2026
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Published July 8, 2026 · Recall initiated: June 16, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Accuray Incorporated
- Distributor
- 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.
- Lot
- All systems prior with software version 11X that utilize the Exchange Table
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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