FDA Device recall Z-2290-2018
RayStation Radiation Therapy Treatment Planning System
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of RayStation Radiation Therapy Treatment Planning System by Raysearch Laboratories Ab, citing the dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2290-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-28 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: 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. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Reason
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
Identifiers
| code_info | 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 and 7.0.0.19 |
|---|
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-2290-2018%22
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