RaySearch Laboratories recalls RayStation 6 Service Pack 3 software update with UDI #07350002010242 due to potential underestimation of radiation dose in treatment planning. 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 6 Service Pack 3 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 affects dose calculation algorithms for radiation therapy planning. This could result in the system underestimating the radiation dose delivered to tumors, potentially reducing treatment effectiveness. However, the error does not cause immediate harm or injury during normal use.
Medical professionals using RayStation 6 for radiation therapy or medical oncology treatments. Patients receiving radiation therapy through this software may be at risk if the dose is underestimated.
Check if you have RayStation 6 Service Pack 3 with UDI #07350002010242. This software update was used for radiation therapy and medical oncology treatments.
Reach out to RaySearch Laboratories for guidance on the recall and next steps.
The software error could result in underestimation of radiation dose, but it does not cause immediate harm or injury during normal use.
Check for UDI #07350002010242 on your RayStation 6 Service Pack 3 software update.
Contact RaySearch Laboratories for guidance on the recall and next 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-2343-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2343-2020 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.
