RayStation Radiation Therapy Treatment Planning System — Class II medical device recall Z-1310-2015
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2015-04-01, distributed nationwide. An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned ab
| Recall number | Z-1310-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, Sweden |
| Recall initiated | 2015-03-04 |
| Classified | 2015-03-20 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2017-09-20 |
| Distributed | Nationwide (US) |
| Quantity | 245 units |
Product
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Reason for recall
An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.
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-1310-2015. 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.