Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2644-2026 — Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

U.S. FDA — Device Enforcement · United States · 2026-06-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2644-2026
Date of alert
2026-06-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Accuray Incorporated
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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