FDA Device recall Z-2644-2026
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer
- FDA Device
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer by Accuray, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2644-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-16 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Accuray |
| Distribution | US |
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.
Identifiers
| code_info | ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2644-2026%22
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