RaySearch Laboratories recalls RayStation 6 Service Pack 1 (UDI #s 07350002010037, 07350002010082) due to software error that may underestimate radiation dose in treatment planning. Affected medical devices used in radiation therapy.
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RaySearch Laboratories is recalling RayStation 6 Service Pack 1 software updates that could underestimate radiation dose during cancer treatment. This error might lead to inadequate radiation delivery, potentially affecting treatment effectiveness.
The software error affects dose calculation algorithms for pencil beam scanning and line scanning in radiation therapy. This could result in underestimating the radiation dose delivered to tumors, potentially reducing treatment effectiveness.
Medical professionals using RayStation 6 Service Pack 1 for radiation therapy or medical oncology treatments. Patients receiving radiation therapy through this software may be at risk if the dose calculation is inaccurate.
Check for UDI numbers 07350002010037 or 07350002010082 on RayStation 6 Service Pack 1 software. These units were used in radiation therapy and medical oncology settings.
Verify your RayStation 6 version matches build number 6.1.1.2 to confirm if affected.
The software error could result in underestimating radiation dose, potentially reducing treatment effectiveness, but does not cause immediate harm.
Check for UDI numbers 07350002010037 or 07350002010082 on your RayStation 6 Service Pack 1 software.
Verify your software version matches build number 6.1.1.2. If affected, contact RaySearch Laboratories for guidance.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2352-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2352-2020 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.
