MRIdian ViewRay Radiation Therapy System — Class II medical device recall Z-1309-2016
Terminated recall by Viewray Incorporated, reported 2016-04-06, distributed in CA, FL, MO, WI. When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points sc
| Recall number | Z-1309-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viewray Incorporated, Oakwood Village, OH, United States |
| Recall initiated | 2016-03-07 |
| Classified | 2016-03-31 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2017-02-22 |
| Distributed | CA, FL, MO, WI |
| Countries outside the US | KR, NL |
| Quantity | 5 units |
| Reason classes | software |
| Serial numbers | 100, 101, 102, 104, 105 |
| Model numbers | 10000 |
Product
MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated
Reason for recall
When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.
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-1309-2016. 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.