RayStation 4 — Class II medical device recall Z-0294-2019
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2018-11-07, distributed nationwide. Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation
| Recall number | Z-0294-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2018-09-21 |
| Classified | 2018-10-30 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2020-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 110 units |
Product
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Reason for recall
Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
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-0294-2019. 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.