Radiation therapy software — Class II medical device recall Z-2039-2023
Terminated recall by RaySearch America Inc, reported 2023-07-05, distributed in AZ, CA, GA, WA. A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions:
| Recall number | Z-2039-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RaySearch America Inc, New York, NY, United States |
| Recall initiated | 2021-01-22 |
| Classified | 2023-06-29 |
| Reported by FDA | 2023-07-05 |
| Terminated | 2023-07-03 |
| Distributed | AZ, CA, GA, WA |
| Quantity | 5 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07350002010129, 07350002010174, 07350002010204, 07350002010235, 07350002010266, 07350002010297, 07350002010303, 07350002010310, 07350002010365 |
| Model numbers | 10A, 10B, SP1, SP2 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2039-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.