RayStation standalone software radiation therapy treatment planning… — Class II medical device recall Z-1598-2021
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2021-05-26, distributed in TN. When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrec
| Recall number | Z-1598-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2021-04-07 |
| Classified | 2021-05-14 |
| Reported by FDA | 2021-05-26 |
| Terminated | 2023-06-02 |
| Distributed | TN |
| Model numbers | 10A, 10B |
Product
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
Reason for recall
When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.
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-1598-2021. 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.