RayStation 9B SP1 — Class II medical device recall Z-1403-2022
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2022-07-27, distributed nationwide. An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been id
| Recall number | Z-1403-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2022-06-01 |
| Classified | 2022-07-19 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2023-10-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH |
| Quantity | 1 |
Product
RayStation 9B SP1. For radiation treatment planning.
Reason for recall
An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
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-1403-2022. 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.