RayStation Radiation Therapy Treatment Planning System — Class II medical device recall Z-2290-2018
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2018-07-04, distributed nationwide. The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to
| Recall number | Z-2290-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, Sweden |
| Recall initiated | 2018-03-28 |
| Classified | 2018-06-26 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2020-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 728 |
Product
RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Reason for recall
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
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-2290-2018. 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.