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.
Check against the official notice below — it lists the full affected range.
RaySearch America Inc is recalling RayStation radiation therapy treatment planning software due to a software bug that produces incorrect results when deep learning segmentation is used followed by certain geometrical functions, including the Create wall function, Expand Contract function, or ROI algebra function. If incorrect dose statistics from these faulty results are used to determine whether a radiation treatment plan is acceptable, an inappropriate plan could be approved for patient treatment, potentially resulting in either a more conservative or more liberal dose plan than intended.
The recall affects five systems distributed in Arizona, California, Georgia, and Washington. The affected software versions include models 8B through 10B with various service packs. The source document does not specify any remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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 Quantity: 5 systems 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.