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.
- Company
- Raysearch America Inc
- Recall Initiated
- January 22, 2021
- Posted
- June 29, 2023
- Terminated
- July 3, 2023
- Recall Number
- Z-2039-2023
- Quantity
- 5 systems
- Firm Location
- York, NY
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
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.