RaySearch Laboratories recalls RayStation 8A software version 8.0.0.61 due to potential underestimation of radiation dose during cancer treatment. Affected units have UDI # 07350002010112.
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 8A software version 8.0.0.61 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 cause the system to underestimate the radiation dose delivered to patients, potentially resulting in inadequate cancer treatment.
Medical professionals using RayStation 8A for radiation therapy or cancer treatment. Patients receiving treatment with this software version are at risk of receiving insufficient radiation doses.
Check for the UDI number 07350002010112 and build number 8.0.0.61 on the software. The product is used for radiation therapy and medical oncology treatments.
Verify the build number is 8.0.0.61 and UDI number is 07350002010112
The software error could result in underestimation of radiation dose, potentially leading to inadequate treatment. However, the recall indicates it is a low-risk issue requiring software update.
Check for UDI number 07350002010112 and build number 8.0.0.61 on the software.
The recall does not specify a remedy, so you should check for updates or contact RaySearch Laboratories for guidance.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2344-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2344-2020 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.
