ViewRay MRIdian Linac System: Model No — Class II medical device recall Z-1836-2021
Terminated recall by Viewray, Inc., reported 2021-06-16. Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) softwa
| Recall number | Z-1836-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viewray, Inc., Mountain View, CA, United States |
| Recall initiated | 2021-05-04 |
| Classified | 2021-06-09 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2023-10-19 |
| Countries outside the US | CH, DE, FR, IT |
| Quantity | 8 versions |
| Reason classes | software |
| Serial numbers | 108, 203, 214, 215, 226, 232, 240, 244 |
| Model numbers | 20000-01 |
Product
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.
Reason for recall
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
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-1836-2021. 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.