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 set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll. |
| Product | CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. |
| Quantity | 243 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AK, AZ. CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, WV, PR and the countries of Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Republic of … |
| Initiated | 2021-02-26 |
| Classified | 2021-03-17 |
| Terminated | 2022-06-27 |
| Recall number | Z-1272-2021 |
| 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-1272-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87439/
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