MRIdian ViewRay Radiation Therapy System — Class II medical device recall Z-0806-2016
Terminated recall by Viewray Incorporated, reported 2016-02-24, distributed in CA, FL, MO, WI. The system loaded a completion fraction in the incorrect order after a treatment interruption.
| Recall number | Z-0806-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viewray Incorporated, Oakwood Village, OH, United States |
| Recall initiated | 2015-12-24 |
| Classified | 2016-02-12 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2017-02-22 |
| Distributed | CA, FL, MO, WI |
| Countries outside the US | KR |
| Quantity | 5 units |
| Serial numbers | 100, 101, 102, 104, 105 |
| Model numbers | 10000 |
Product
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Reason for recall
The system loaded a completion fraction in the incorrect order after a treatment interruption.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0806-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.