Recall Z-2644-2026— Accuray Incorporated
Class II · Ongoing
Class II FDA medical device recall by Accuray Incorporated, initiated 2026-06-16. Product: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator. 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..
- Recalling firm
- Accuray Incorporated
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-16
- Firm location
- Madison, WI, United States
Product description
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.