RaySearch Laboratories recalls RayStation 8B Service Pack 2 software update with UDI #07350002010235 due to potential dose calculation errors in radiation therapy treatments.
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 8B Service Pack 2 software updates that could underestimate radiation dose calculations during cancer treatment. This error might lead to inadequate radiation delivery to tumors, potentially affecting treatment effectiveness.
The software error in dose calculation algorithms might cause the system to underestimate the radiation dose delivered to tumors. This could result in insufficient radiation being administered to the target area, potentially reducing treatment effectiveness. However, the error is specific to certain calculation methods and does not cause immediate harm.
Medical professionals using RayStation 8B software for radiation therapy and cancer treatment planning. Patients receiving radiation therapy through this system could be at risk if the software error affects dose calculations.
Check for the UDI number 07350002010235 on the software update. The affected version is RayStation 8B Service Pack 2 with build number 8.1.2.5 used in radiation therapy and medical oncology applications.
Verify your RayStation software version matches the affected build number 8.1.2.5 with UDI #07350002010235.
The software error could lead to underestimation of radiation dose during treatment, potentially reducing effectiveness. However, it does not cause immediate harm to patients or staff.
Look for the UDI number 07350002010235 and build number 8.1.2.5 on the RayStation 8B Service Pack 2 software update.
No immediate action is required. The recall involves checking the software version and updating to a corrected version if needed.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2348-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2348-2020 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.
