FDA-Device2026-07-08Class II
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
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.
Sold states
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.
Affected count
48 units
Manufactured in
1240 Deming Way, N/A, Madison, WI, United States
Products
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2640-2026More Accuray Incorporated recalls
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