RayStation — Class II medical device recall Z-2138-2021
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2021-08-04, distributed in TN. Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
| Recall number | Z-2138-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2021-06-08 |
| Classified | 2021-07-23 |
| Reported by FDA | 2021-08-04 |
| Terminated | 2024-03-20 |
| Distributed | TN |
| Countries outside the US | BE |
| Quantity | 5 units |
| UPC / GTIN / UDI-DI | 07350002010174, 07350002010266, 07350002010297, 07350002010303, 07350002010310, 07350002010365, 07350002010389 |
Product
RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297; RayStation 10.0 (10.0.0.1154) 07350002010303; RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365; RayStation 10.1 (10.1.0.613) 07350002010310; RayStation 11.0 (11.0.0.951) 07350002010389;
Reason for recall
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
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-2138-2021. 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.