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 | 292 units |
| Distribution | Worldwide - US Nationwide and and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kenya, Korea, Republic of, Liechtenstein, Lithuania, Luxembourg, Macao, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Sw… |
| Initiated | 2026-06-16 |
| Classified | 2026-07-01 |
| Recall number | Z-2644-2026 |
| 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-2644-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99083/
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