RaySearch Laboratories recalls RayStation 8A Service Pack 1 software update with UDI #07350002010136 due to potential underestimation of radiation dose in treatment planning. Affected users should contact the manufacturer for remediation.
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 Service Pack 1 software updates that could underestimate radiation dose during cancer treatment. This error might lead to inadequate radiation delivery, potentially affecting treatment effectiveness.
The software error in dose calculation algorithms might cause the system to underestimate the radiation dose delivered to tumors. This could result in insufficient radiation being administered, potentially reducing treatment effectiveness. However, the error does not cause immediate harm or injury during normal use.
Medical professionals using RayStation 8A for radiation therapy or medical oncology treatments. Patients receiving radiation therapy through this system could be at risk if the software error affects dose calculation.
Check if your RayStation 8A software version is 8.0.1.10 with UDI number 07350002010136. The product is used for radiation therapy and medical oncology treatments.
Reach out to RaySearch Laboratories for guidance on the software update and remediation steps.
The software error could result in underestimating radiation dose during treatment, which might reduce treatment effectiveness. However, it does not cause immediate injury or death.
Check your RayStation 8A software version: if it is 8.0.1.10 with UDI number 07350002010136, you are affected.
Contact RaySearch Laboratories for guidance on the software update and remediation steps.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2345-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2345-2020 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.
