RaySearch Laboratories recalls RayStation 6 software version 6.0.0.24 due to a potential dose calculation error in radiation therapy. Affected units may underestimate radiation dose, requiring immediate action.
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 software version 6.0.0.24 because a software error could cause radiation therapy to underestimate the dose delivered to patients. This might lead to inadequate treatment if the software fails to calculate radiation doses correctly.
The software error in the dose calculation algorithms could result in the system underestimating the radiation dose delivered to patients. This might lead to inadequate treatment if the system fails to calculate the correct dose during radiation therapy procedures.
Medical professionals using RayStation 6 for radiation therapy or medical oncology treatments. Patients receiving radiation therapy using this software may be at risk if the dose calculation error affects treatment accuracy.
Check for the software version 6.0.0.24 with UDI number 07350002010013. The product is used for radiation therapy and medical oncology treatments.
Verify the software version by checking the build number on the device.
The software error could result in a local underestimation of expected radiation dose, potentially leading to inadequate treatment. However, the risk level is considered low for most users.
Check the build number on the device; affected units have version 6.0.0.24 with UDI number 07350002010013.
The recall does not specify a remedy, so users should check the software version and contact RaySearch Laboratories for further instructions.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2341-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2341-2020 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.
