Radiation Therapy Treatment Planning System — Class II medical device recall Z-1815-2017
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2017-04-19, distributed nationwide. An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a n
| Recall number | Z-1815-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2017-01-18 |
| Classified | 2017-04-12 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2019-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 741 units |
| Reason classes | software |
| Model numbers | 4.5, 4.7, 5.0 |
Product
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 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. The system functionality can be configured based on user needs
Reason for recall
An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an erroneous calculation may be allowed.
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-1815-2017. 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.