RayStation/RayPlan 8A — Class II medical device recall Z-1462-2020
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2020-03-18, distributed in TN. There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll c
| Recall number | Z-1462-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, Sweden |
| Recall initiated | 2020-02-20 |
| Classified | 2020-03-10 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2024-11-05 |
| Distributed | TN |
| Quantity | 1 systems |
| UPC / GTIN / UDI-DI | 07350002010112 |
Product
RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
Reason for recall
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
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-1462-2020. 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.