MRIdian¿ ViewRay¿ Radiation Therapy System — Class II medical device recall Z-0115-2016
Terminated recall by Viewray Incorporated, reported 2015-10-21, distributed in CA, MO, WI. ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or c
| Recall number | Z-0115-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viewray Incorporated, Oakwood Village, OH, United States |
| Recall initiated | 2015-08-27 |
| Classified | 2015-10-09 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2017-06-09 |
| Distributed | CA, MO, WI |
| Countries outside the US | KR |
| Quantity | 4 units |
| Serial numbers | 100, 101, 102, 105 |
| Model numbers | 10000 |
Product
MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ 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
ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
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-0115-2016. 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.