RaySearch Laboratories recalls RayStation treatment planning software versions 6.0.0.24 to 10.1.0.613 due to potential misleading dose evaluations after clinical goal edits. Affected users should contact support for updates.
Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A.
RaySearch Laboratories is recalling several versions of their RayStation treatment planning software because editing clinical goals can lead to misleading dose evaluations. This could affect radiation therapy planning accuracy, but the recall does not require immediate discontinuation of use.
Editing clinical goals in RayStation can cause dose distributions to appear misleading, especially when slice spacing is less than 1 mm. This issue exists in versions from 6 up to 10A and may impact treatment accuracy.
Medical professionals using RayStation software for radiation therapy planning are most at risk. Patients receiving treatment through this software may be affected if the software is used without updates.
Check if your RayStation software version is listed in the recall: 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.6, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, or 10.0.1.52.
Identify your RayStation version by checking the software menu or documentation.
Reach out to RaySearch Laboratories for updates or alternative solutions.
The recall addresses potential inaccuracies in dose evaluation, but it does not pose an immediate risk to patients. Users should follow the recommended steps to ensure treatment accuracy.
No, the recall does not require stopping use. Users can continue using the software but should check for updates and contact support for guidance.
Versions from 6.0.0.24 to 10.1.0.613, including RayPlan 2 and some service packs, are affected.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1838-2021 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1838-2021 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.
