RayStation Product Usage: is a software system designed for treatment… — Class II medical device recall Z-0380-2018
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2018-01-24, distributed nationwide. For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is
| Recall number | Z-0380-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2017-07-17 |
| Classified | 2018-01-16 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2018-08-29 |
| Distributed | Nationwide (US) |
| Quantity | 117 units |
Product
RayStation Product Usage: 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.
Reason for recall
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
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-0380-2018. 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.