MRIdian Linac Radiation Therapy System Model 10000 and 20000 — Class II medical device recall Z-0676-2020
Terminated recall by Viewray, Inc., reported 2019-12-18, distributed in CA, FL, IL, MI, MO, NY, WI. Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring
| Recall number | Z-0676-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viewray, Inc., Mountain View, CA, United States |
| Recall initiated | 2019-03-03 |
| Classified | 2019-12-12 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2021-04-28 |
| Distributed | CA, FL, IL, MI, MO, NY, WI |
| Countries outside the US | AE, DE, DK, FR, IT, JP, KR, NL, TR |
| Quantity | 24 systems |
| Reason classes | software |
| Serial numbers | 100, 101, 102, 103, 104, 105, 107, 108, 112, 113, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225 |
| Model numbers | 10000, 20000 |
Product
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Reason for recall
Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.
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-0676-2020. 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.