RayStation 4 — Class II medical device recall Z-2457-2015
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2015-09-02, distributed in CO, IL, MI, NC, OH, TN, WA. Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used
| Recall number | Z-2457-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2015-05-27 |
| Classified | 2015-08-25 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2017-09-22 |
| Distributed | CO, IL, MI, NC, OH, TN, WA |
| Quantity | 126 programs |
| Reason classes | software |
Product
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
Reason for recall
Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
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-2457-2015. 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.