RayStation Therapy Treatment Planning System — Class II medical device recall Z-1419-2013
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2013-06-05, distributed in CT, FL, MA, MO, NY, OH. Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in
| Recall number | Z-1419-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2013-02-15 |
| Classified | 2013-05-28 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2017-02-17 |
| Distributed | CT, FL, MA, MO, NY, OH |
| Countries outside the US | AU, CA, CH, DE, IT, NL |
| Model numbers | 2.0, 2.5, 3.0 |
Product
RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Reason for recall
Under some circumstances, imported CT, MR and PET images are offset from their true positions by one pixel in one or two directions. Users must be aware of this information to avoid incorrect dose calculations during treatment planning.
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-1419-2013. 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.