RaySearch Laboratories recalls RayStation 11B software versions 12.0.0.932, 12.1.0.1221, 12.0.3.68 due to potential misleading Linear Energy Transfer (LET) displays in dose evaluations and beam-specific distributions.
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.
RaySearch Laboratories is recalling specific versions of their RayStation 11B software. These versions may show inaccurate Linear Energy Transfer (LET) values, which could lead to incorrect radiation treatment planning in medical imaging. This matters because precise LET measurements are critical for safe and effective radiation therapy.
The software may display misleading Linear Energy Transfer (LET) values when evaluating dose thresholds and beam-specific LET distributions. This could lead to inaccurate radiation treatment planning, potentially affecting the precision of radiation therapy for patients.
Medical professionals using RayStation 11B software versions 12.0.0.932, 12.1.0.1221, and 12.0.3.68 for radiation therapy planning are most at risk. Patients receiving treatment through these software versions could potentially receive incorrect radiation doses.
Check if your RayStation 11B software version is 12.0.0.932, 12.1.0.1221, or 12.0.3.68. The software version numbers are listed in the product description.
Verify your RayStation 11B software version by checking the version numbers listed in the product description.
RayStation 11B software versions 12.0.0.932, 12.1.0.1221, and 12.0.3.68.
The recall addresses potential misleading Linear Energy Transfer (LET) displays in dose evaluations and beam-specific distributions, which could affect radiation therapy planning accuracy.
You should check your software version. If you have an affected version, you may need to update to a newer version to resolve the issue.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1299-2022 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1299-2022 from RaySearch Laboratories. 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.
