FDA Device recall Z-0720-2017
Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of…
- FDA Device
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of… by Raysearch Laboratories Ab, citing an error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0720-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-11 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
Radiation Therapy Treatment Planning System Product Usage: 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
An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect. When the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing.
Identifiers
| code_info | Build No: "5.0.0.37 , 5.0.1.11 or 5.0.2.35 . Only 5.0.2.35 was distributed in the U.S. |
|---|
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-0720-2017%22
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