RaySearch Laboratories recalls RayStation 9A software version 9.0.0.113 due to potential underestimation of radiation dose during cancer treatment. Affected units may require correction to ensure safe treatment planning.
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 9A software version 9.0.0.113 used in radiation therapy. This software error could cause the system to underestimate radiation dose, potentially leading to inadequate treatment. Patients and staff should verify their software version to determine if they are affected.
The software error in the dose calculation algorithms could cause the system to underestimate the radiation dose delivered to tumors. This might result in inadequate treatment if the system does not correctly calculate the required radiation levels. However, the error is specific to the software version and does not cause immediate harm during normal use.
Healthcare providers using RayStation 9A software for radiation therapy or medical oncology treatments are likely affected. Staff and patients using this system may be at risk if the software error impacts treatment planning.
Check for the software version number 9.0.0.113 on your RayStation 9A system. The recall applies to units with the UDI # 07350002010174.
Verify your RayStation 9A software version by checking the build number in the system settings.
The software error could cause the system to underestimate radiation dose during treatment planning, but it does not cause immediate harm. Affected users should check their software version to determine if they need action.
Your RayStation 9A is affected if it has the software version 9.0.0.113 and the UDI # 07350002010174.
Check your software version and contact RaySearch Laboratories for guidance on whether 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-2349-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2349-2020 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.
