Treatment Planning and Delivery System Software version 3 — Class II medical device recall Z-1954-2015
Terminated recall by Viewray Incorporated, reported 2015-07-08, distributed in CA, MO, WI. The software was failing to determine new patient locations if imaging is not enabled during treatment.
| Recall number | Z-1954-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viewray Incorporated, Oakwood Village, OH, United States |
| Recall initiated | 2015-05-07 |
| Classified | 2015-07-02 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2016-02-04 |
| Distributed | CA, MO, WI |
| Quantity | 3 |
| Reason classes | software |
| Serial numbers | 100, 101, 102 |
| Model numbers | 10000 |
Product
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
The software was failing to determine new patient locations if imaging is not enabled during treatment.
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-1954-2015. 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.