RayStation standalone software treatment planning system — Class II medical device recall Z-2426-2020
Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2020-07-01. It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import
| Recall number | Z-2426-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2020-05-26 |
| Classified | 2020-06-24 |
| Reported by FDA | 2020-07-01 |
| Countries outside the US | BE |
| Quantity | 12 |
| Model numbers | 8.0, 8.1, 9.0, 9.1, 9.2 |
Product
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
Reason for recall
It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.
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-2426-2020. 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.