FDA Device recall Z-0866-2020
RayStation stand-alone software treatment planning system
- FDA Device
- Class II
- terminated
- Published 2020-02-05
On 2020-02-05 the FDA classified a Class II recall of RayStation stand-alone software treatment planning system by Raysearch Laboratories Ab, citing three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0866-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-19 |
| Published | 2020-02-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
Reason
Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.
Identifiers
| code_info | Software Versions Numbers: 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.3.0.14 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 ,…Software Versions Numbers: 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.3.0.14 , 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 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 5.0.2.35 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 . |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0866-2020%22
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