RaySearch Laboratories recalls RayStation 8B software version 8.1.0.47 due to potential underestimation of radiation dose in treatment planning. Affected units may require software updates or corrections to ensure safe 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 8B software version 8.1.0.47 used in radiation therapy. This version could underestimate the radiation dose delivered to patients, potentially leading to inadequate treatment. Users should contact RaySearch for guidance on safe use or updates.
The software has a calculation error in dose algorithms that might not properly measure the radiation dose a patient receives. This could mean the treatment is less effective than intended, but it does not cause immediate harm or injury.
Medical professionals using RayStation 8B software for radiation therapy and medical oncology treatments. Patients receiving radiation therapy using this software may be at risk if the dose is underestimated.
Check for the software version number 8.1.0.47 on the RayStation 8B system. The product was sold with the UDI number 07350002010129.
Verify the software version number on your RayStation 8B system to see if it is 8.1.0.47.
Reach out to RaySearch Laboratories for guidance on whether a software update or correction is needed.
The software error could lead to an underestimation of radiation dose, but it does not cause immediate injury or death. It may affect treatment effectiveness.
Check the software version number on your RayStation 8B system; affected units have version 8.1.0.47 with UDI number 07350002010129.
Contact RaySearch Laboratories for instructions on whether a software update or correction is 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-2346-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2346-2020 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.
