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 not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error. |
| Product | ViewRay System, Radiation Therapy System |
| Quantity | 1 |
| Distribution | US distribution to MO. |
| Initiated | 2015-01-15 |
| Classified | 2015-05-05 |
| Terminated | 2015-09-23 |
| Recall number | Z-1580-2015 |
| 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-1580-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71050/
Alerts for Viewray Systems, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.