RaySearch Laboratories recalls RayStation 5 Service Pack 3 (UDI #07350002010020) due to software error that may cause radiation dose underestimation in cancer treatment. Affected users should contact for remedy.
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 5 Service Pack 3 software updates that could underestimate radiation doses during cancer treatment. This error might lead to inadequate treatment if not corrected, potentially affecting patient safety.
The software error in dose calculation algorithms may cause the system to underestimate the radiation dose delivered to tumors. This could result in insufficient treatment for cancer patients, potentially leading to treatment failure.
Medical professionals using RayStation 5 for radiation therapy or cancer treatment. Patients receiving radiation therapy through this system are at risk if the software error affects dose calculations.
Check if you have RayStation 5 Service Pack 3 with UDI # 07350002010020. The build number is 5.0.3.17. This software update is used for radiation therapy and medical oncology treatments.
Verify your RayStation 5 version matches the UDI # 07350002010020 with build number 5.0.3.17.
The software error could cause radiation dose underestimation, potentially leading to inadequate treatment. However, the recall indicates it's a software update that needs correction.
Check for UDI # 07350002010020 and build number 5.0.3.17 in your RayStation 5 software.
The recall does not specify a remedy, so 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-2340-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2340-2020 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.
