RayStation 3 — Class II medical device recall Z-2206-2016
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2016-07-27, distributed in CA, CT, DE, FL, HI, ME, MO, NY…. An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStat
| Recall number | Z-2206-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2016-07-01 |
| Classified | 2016-07-15 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2017-09-25 |
| Distributed | CA, CT, DE, FL, HI, ME, MO, NY, OH, TX, WA |
| Quantity | 170 units |
Product
RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.
Reason for recall
An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation 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-2206-2016. 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.