# FDA recall Z-2039-2023

> **RaySearch America Inc** · Class II · device recall initiated 2021-01-22.

## 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.

## Distribution

US: AZ, CA, GA & WA

## Key facts

- **Recall number:** Z-2039-2023
- **Recalling firm:** RaySearch America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-22
- **Report date:** 2023-07-05
- **Termination date:** 2023-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2039-2023

## Citation

> AI Analytics. FDA recall Z-2039-2023. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-2039-2023. Source: US FDA. Licensed CC0.

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