RaySearch America Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
RaySearch America Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
RaySearch America Inc is recalling Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: due to A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract f. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Field Safety Notice 73474 was emailed January 22, 2021 to affected customers. The notice identifies affected RayStation models: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B running software versions RS 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. Users are instructed not to use Create wall, Expand/Contract, or ROI algebra functions directly on ROIs created by the DL segmentation. Instead, convert the ROIs to contour or mesh representation before using the affected functions. Users are to confirm they read and understood the notice by replying to the email. Error fixed in RS 10B Service Pack 1 and corrected in the next version of RayStation.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, GA, WA
Page updated: Jan 10, 2026