Class II — Viewray Incorporated
| Recalling firm | Viewray Systems, Inc. |
|---|---|
| Registered facility | VIEWRAY SYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The software was failing to determine new patient locations if imaging is not enabled during treatment. |
| Product | Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. |
| Quantity | 3 |
| Distribution | Distributed in the states of CA, MO & WI. |
| Initiated | 2015-05-07 |
| Classified | 2015-07-02 |
| Terminated | 2016-02-04 |
| Recall number | Z-1954-2015 |
| 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 — Viewray Incorporated (Z-1954-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71505/
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