RaySearch Ray Station — Class II medical device recall Z-1308-2014
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2014-04-09, distributed in FL, IL, MA, MD, NJ, OH, WA. RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors
| Recall number | Z-1308-2014 |
|---|---|
| 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 | 2014-03-31 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2017-02-17 |
| Distributed | FL, IL, MA, MD, NJ, OH, WA |
| Countries outside the US | ES, GB, IT |
| Reason classes | software |
| Model numbers | 4.30 |
Product
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Reason for recall
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
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-1308-2014. 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.