Class II — Accuray Incorporated
| Recalling firm | Accuray Incorporated |
|---|---|
| Registered facility | Accuray Incorporated (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife® Systems with software version 1 0.6. |
| Product | CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. |
| Quantity | 40 affected devices |
| Distribution | Worldwide Distribution - US Distribution to the states of : PA, WA, MT, NY, SC, CA, MN, AK, NJ, FL, KY, WI., and to the countries of : Bulgaria, Canada, France, Germany, India, Japan, Luxembourg, Netherlands, Portugal, Switzerland and Turkey |
| Initiated | 2016-11-22 |
| Classified | 2016-12-12 |
| Terminated | 2017-05-22 |
| Recall number | Z-0734-2017 |
| 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-0734-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75863/
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