FDA Device recall Z-2039-2023
Radiation therapy software, RayStation standalone software treatment planning system
- FDA Device
- Class II
- terminated
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of Radiation therapy software, RayStation standalone software treatment planning system by Raysearch America, citing A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra functi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2039-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-22 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Raysearch America |
| Distribution | AZ, CA, GA, WA |
Product
Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.
Reason
A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.
Identifiers
| code_info | UDI-DI: 07350002010129 UDI-DI: 07350002010204 UDI-DI: 07350002010235 UDI-DI: 07350002010174 UDI-DI: 07350002010266…UDI-DI: 07350002010129 UDI-DI: 07350002010204 UDI-DI: 07350002010235 UDI-DI: 07350002010174 UDI-DI: 07350002010266 UDI-DI: 07350002010297 UDI-DI: 07350002010303 UDI-DI: 07350002010365 UDI-DI: 07350002010310 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2039-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.