Class II — Accuray Incorporated
| Recalling firm | Accuray Incorporated |
|---|---|
| Registered facility | Accuray Incorporated (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. |
| Product | TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. |
| Quantity | 7 units |
| Distribution | Worlwide distribution - US Nationwide distribution including in the states of CA, FL, IL, ND, NJ, OK, UT and the countries of Australia, China, Italy, Switzerland, United Arab Emirates. |
| Initiated | 2020-12-10 |
| Classified | 2021-01-07 |
| Terminated | 2022-09-26 |
| Recall number | Z-0784-2021 |
| 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-0784-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86993/
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