Company: RaySearch America Inc
Date of Enforcement Report: 07/03/2023
Class II
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.
Recall Number:
Z-2039-2023
REASON:
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.
RECALLING FIRM/MANUFACTURER:
RaySearch America Inc
VOLUME OF PRODUCT IN COMMERCE:
5 systems
DISTRIBUTION:
US: AZ, CA, GA & WA
