Official recall notice
FDA DeviceClass IINotable
FDA Recall: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Acc
- Recall date
- 2026-07-08
- Brand
- Accuray Incorporated
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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 products
ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.