ViewRay System — Class II medical device recall Z-1580-2015
Terminated recall by Viewray Incorporated, reported 2015-05-13. The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate co
| Recall number | Z-1580-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viewray Incorporated, Oakwood Village, OH, United States |
| Recall initiated | 2015-01-15 |
| Classified | 2015-05-05 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2015-09-23 |
| Quantity | 1 |
| Reason classes | software |
Product
ViewRay System, Radiation Therapy System
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.