RaySearch Laboratories recalls RayStation 8B Service Pack 1 (UDI #07350002010204) due to software error potentially causing underestimated radiation dose in cancer treatments. Affected users should contact for updates.
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 1 software updates that could underestimate radiation doses during cancer treatment. This could lead to inadequate treatment if the software error isn't fixed.
The software error in dose calculation algorithms might cause the system to underestimate the radiation dose delivered to tumors. This could result in inadequate treatment if the error isn't corrected, potentially affecting cancer treatment outcomes.
Medical professionals using RayStation 8B for radiation therapy or medical oncology treatments. Patients receiving cancer treatments with this software are at risk if the dose calculation error occurs.
Check if your RayStation 8B software version is 8.1.1.8 with UDI #07350002010204. The product is used for radiation therapy and medical oncology treatments.
Verify your RayStation 8B version is 8.1.1.8 with UDI #07350002010204.
The software error could lead to underestimated radiation doses during cancer treatment, potentially affecting treatment effectiveness.
Check if your RayStation 8B version is 8.1.1.8 with UDI #07350002010204.
Contact RaySearch Laboratories for updates on the software fix.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2347-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2347-2020 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.
