FDA Device recall Z-2426-2020
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9…
- FDA Device
- Class II
- ongoing
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class II recall of RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9… by Raysearch Laboratories Ab, citing it is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found wi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2426-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-05-26 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | n/a |
Product
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
Reason
It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.
Identifiers
| code_info | Software versions 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 and 9.2.0.483 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2426-2020%22
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