RaySearch America recalls RayStation software versions 8.1-10.1 for incorrect radiation treatment planning. The software bug may cause unsafe treatment plans if deep learning segmentation is used. Affected models include 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1, 10B.
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.
RaySearch America is recalling its RayStation radiation therapy software versions 8.1 through 10.1. The software bug can cause incorrect treatment plans when using deep learning segmentation features, potentially leading to unsafe radiation therapy. This affects medical professionals using the software for cancer treatment planning.
The software bug causes incorrect results when using deep learning segmentation followed by certain geometric functions. If dose statistics from an incorrectly created treatment area are used to approve a radiation plan, it could result in a treatment plan that is too conservative or too aggressive.
Medical professionals using RayStation software for radiation therapy treatment planning are affected. Those who have the specific software versions and model numbers listed in the recall are most at risk.
Check if you have RayStation software versions 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. The affected models include 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1, and 10B.
Verify your RayStation software version by checking the software's version number in the settings menu.
Reach out to RaySearch America directly for assistance with the recall process.
The software may have a bug that causes incorrect treatment plans if deep learning segmentation is used with certain functions. It is not safe to use without checking for the recall.
Check your software version and model number to see if you are affected. Contact RaySearch America for guidance.
Look for software versions 8.1, 9.0, 9.1, 9.2, 10.0, 10.1 and model numbers 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1, or 10B.
We’ve drafted a message you can send RaySearch America to request your refund or repair — edit it as you like.
Subject: Recall Z-2039-2023 — RaySearch America RaySearch America Hello, I own a RaySearch America that is covered by recall Z-2039-2023 from RaySearch America. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
