RayStation Radiation Therapy Treatment Planning System — Class II medical device recall Z-1307-2014
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2014-04-09, distributed in AZ, CA, CO, CT, DE, FL, IL, MD…. Potential for dose errors due to software program errors.
| Recall number | Z-1307-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2014-02-06 |
| Classified | 2014-03-28 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2017-02-17 |
| Distributed | AZ, CA, CO, CT, DE, FL, IL, MD, MS, NJ, NY, OH, PA, TN, WA |
| Countries outside the US | AU, BE, CH, CN, DE, ES, GB, IT, KR, NO, NZ |
| Reason classes | software |
| Model numbers | 2.5, 3.0, 3.5, 4.0 |
Product
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Reason for recall
Potential for dose errors due to software program errors.
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-1307-2014. 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.