RayStation 4 — Class II medical device recall Z-1597-2021
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2021-05-26, distributed nationwide. For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose e
| Recall number | Z-1597-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2021-02-22 |
| Classified | 2021-05-14 |
| Reported by FDA | 2021-05-26 |
| Terminated | 2023-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 116 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07350002010013, 07350002010020, 07350002010068, 07350002010075, 07350002010082, 07350002010112, 07350002010129, 07350002010136, 07350002010174, 07350002010204, 07350002010235, 07350002010242, 07350002010266, 07350002010297, 07350002010303, 07350002010310, 07350002010365 |
Product
RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
Reason for recall
For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.
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-1597-2021. 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.