Radiation Therapy Treatment Planning System software RayStation is a… — Class II medical device recall Z-2785-2015
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2015-09-23, distributed nationwide. An error caused by a floating point precision problem tends to cause a problem with the display of isodose lin
| Recall number | Z-2785-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, Sweden |
| Recall initiated | 2015-05-29 |
| Classified | 2015-09-17 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2017-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, DE, ES, FR, GB, IT, NZ, SE |
| Quantity | 20 devices |
Product
Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
Reason for recall
An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
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-2785-2015. 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.