Class II — Accuray Incorporated
| Recalling firm | Accuray Incorporated |
|---|---|
| Registered facility | Accuray Incorporated (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient. |
| Product | CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: 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 | 226 |
| Distribution | Worldwide Distribution. US Nationwide, Venezuela, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Spain, Saudi Arabia, Russia, Poland, Pakistan, Myanmar, Mexico, Korea, Japan, Italy, Ireland, India, Greece, Germany, France, Finland, Czech Republic, Colombia, China, Canada, and Belgium. |
| Initiated | 2016-01-22 |
| Classified | 2016-02-08 |
| Terminated | 2016-10-20 |
| Recall number | Z-0771-2016 |
| 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-0771-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73193/
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