FDA Device recall Z-2640-2026
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-2640-2026 |
| 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 systems prior with software version 11X 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.
Other recalls by Accuray
- Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer
FDA Device · Class II · 2026-07-08 · Accuray - CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System
FDA Device · Class II · 2025-02-05 · Accuray - Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System
FDA Device · Class II · 2023-09-06 · Accuray - CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for l…
FDA Device · Class II · 2021-03-24 · Accuray - TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radi…
FDA Device · Class II · 2021-01-13 · Accuray
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2640-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.