Ray Station Radiation Therapy Treatment Planning System — Class II medical device recall Z-0281-2014
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2013-11-20, distributed in CA, CO, DE, FL, MD, MO, NJ, NY…. Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.
| Recall number | Z-0281-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, Sweden |
| Recall initiated | 2013-10-23 |
| Classified | 2013-11-14 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2017-02-17 |
| Distributed | CA, CO, DE, FL, MD, MO, NJ, NY, OH, PA, TN, VA |
| Quantity | 195 units |
| Model numbers | 3.0, 3.5, 4.0 |
Product
Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Reason for recall
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
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-0281-2014. 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.