RayStation software version 4 — Class II medical device recall Z-1806-2014
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2014-06-25, distributed nationwide. This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable s
| Recall number | Z-1806-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2014-04-25 |
| Classified | 2014-06-16 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2017-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, DE, ES, FR, GB, IT, KR, NZ |
Product
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Reason for recall
This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
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-1806-2014. 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.