FDA Medical Device · Z-2640-2026

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

Class II · Ongoing

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.

Affected lots / codes — check yours against thisAll systems prior with software version 11X that utilize the Exchange Table

Recalling firm: Accuray Incorporated, Madison, WI
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 48 units
Distribution: 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.
Recall initiated: June 16, 2026
Classified: July 1, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2640-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

Check this brand across all 8 databases →