FDA Device recall Z-1815-2017
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analys…
- FDA Device
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analys… by Raysearch Laboratories Ab, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1815-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-18 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
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
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.
Identifiers
| code_info | 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, 5.0.2.35 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1815-2017%22
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