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Recall Observatory FDA recall evidence

Device product

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

Z-2640-2026

June 16, 2026

Class II

Product summary

Firm
Accuray Incorporated
Event
Event 99075
Status
Ongoing
Classification
Class II
Quantity
48 units
Official record key
device-enforcement:Z-2640-2026

Official wording

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.

Code information: All systems prior with software version 11X that utilize the Exchange Table

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.