ViewRay System: Model No — Class II medical device recall Z-1803-2020
Terminated recall by Viewray, Inc., reported 2020-05-06, distributed in CA, FL, IL, MA, MI, MO, NY, WI. Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy be
| Recall number | Z-1803-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viewray, Inc., Mountain View, CA, United States |
| Recall initiated | 2019-11-18 |
| Classified | 2020-04-27 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2023-02-22 |
| Distributed | CA, FL, IL, MA, MI, MO, NY, WI |
| Countries outside the US | AE, CH, DE, DK, FR, GB, IL, IT, JP, KR, NL, TR |
| Quantity | 32 |
| Reason classes | software |
| Serial numbers | 100, 101, 102, 104, 105, 107, 108, 112, 113, 200, 201, 203, 204, 206, 207, 209, 211, 213, 214, 215, 216, 217, 218, 221, 223 and 10 more |
| Model numbers | 10000, 20000 |
Product
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Reason for recall
Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.
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-1803-2020. 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.