Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Radiation therapy software Recalled by RaySearch America Inc Due to A software bug affecting results when using deep...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact RaySearch America Inc directly.
Affected Products
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.
Quantity: 5 systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 4 states: AZ, CA, GA, WA
About RaySearch America Inc
RaySearch America Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report