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 | ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly. |
| Product | MRIdian® ViewRay® Radiation Therapy System, ViewRay® Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. |
| Quantity | 4 units |
| Distribution | US Distribution to the states of : CA, MO and WI., and Internationally to Korea. |
| Initiated | 2015-08-27 |
| Classified | 2015-10-09 |
| Terminated | 2017-06-09 |
| Recall number | Z-0115-2016 |
| 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 — Viewray Incorporated (Z-0115-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72166/
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