Class II — Accuray Incorporated
| Recalling firm | Accuray Incorporated |
|---|---|
| Registered facility | Accuray Incorporated (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator |
| Quantity | 48 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Republic of, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, Ukraine. |
| Initiated | 2026-06-16 |
| Classified | 2026-07-01 |
| Recall number | Z-2640-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Accuray Incorporated (Z-2640-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99075/
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