MRIdian Linac Radiation Therapy System — Class II medical device recall Z-1251-2019
Terminated recall by Viewray, Inc., reported 2019-05-08, distributed in FL, IL, MI, MO, NY, WI. A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQ
| Recall number | Z-1251-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viewray, Inc., Mountain View, CA, United States |
| Recall initiated | 2019-03-18 |
| Classified | 2019-05-02 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2022-06-16 |
| Distributed | FL, IL, MI, MO, NY, WI |
| Countries outside the US | AE, CH, DE, DK, FR, KR, NL, TR |
| Quantity | 17 devices |
| Serial numbers | 101, 107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228 |
| Model numbers | 20000 |
Product
MRIdian Linac Radiation Therapy System, Model 20000.
Reason for recall
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
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-1251-2019. 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.