Class II — Accuray Incorporated
| Recalling firm | Accuray Incorporated |
|---|---|
| Registered facility | Accuray Incorporated (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach. |
| Product | CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System |
| Quantity | 43 units |
| Distribution | US & Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, Thailand |
| Initiated | 2018-04-10 |
| Classified | 2019-05-31 |
| Terminated | 2021-04-01 |
| Recall number | Z-1697-2019 |
| 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-1697-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82664/
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