RaySearch Laboratories recalls RayStation 9B software version 9.1.0.933 due to a potential radiation dose underestimation error in cancer treatment planning. Affected units may require software updates or recalibration.
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 9B software version 9.1.0.933 used in radiation therapy. This software error could cause the system to underestimate the radiation dose delivered to patients, potentially leading to inadequate treatment.
The software error affects dose calculation algorithms for pencil beam scanning and line scanning. This could result in the system showing a lower radiation dose than what is actually delivered, potentially leading to insufficient treatment for patients.
Medical professionals using RayStation 9B for radiation therapy and cancer treatment planning. Patients receiving radiation therapy using this software may be at risk if the dose is underestimated.
Check if your RayStation software version is 9.1.0.933. The unique device identifier (UDI) #07350002010266 is associated with this specific version.
Verify your RayStation software version is 9.1.0.933 by checking the software settings or documentation.
The recall states this software error could result in a local underestimation of expected dose, which may lead to inadequate treatment. However, the specific risk level is not detailed in the recall notice.
The recall does not specify a remedy, so you should check with RaySearch Laboratories for guidance on potential software updates or recalibration.
The recall notice does not mention a specific deadline for action.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2350-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2350-2020 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.
