RaySearch Laboratories recalls RayStation 7 software version 7.0.0.19 due to potential underestimation of radiation dose in treatment planning. Affected units may require correction to avoid treatment errors.
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 7 software version 7.0.0.19 used in radiation therapy. This version may underestimate radiation dose during treatment planning, potentially leading to unsafe treatment outcomes.
The software has a calculation error in dose algorithms that could result in underestimating the radiation dose delivered to patients. This might cause treatment to be less effective or cause unintended tissue damage.
Medical professionals using RayStation 7 for radiation therapy or medical oncology treatments. Patients receiving radiation therapy through this software may be at risk if the dose calculation error occurs.
Check for the software version 7.0.0.19 with UDI number 07350002010068. The product is used for radiation therapy and medical oncology treatments.
Verify your RayStation software version matches the recalled version 7.0.0.19 with UDI number 07350002010068.
The software error could result in underestimating radiation dose during treatment planning, which might lead to treatment errors. However, the recall indicates it is a software issue that requires correction.
Check for the software version 7.0.0.19 with UDI number 07350002010068. The product is used for radiation therapy and medical oncology treatments.
The recall does not specify a remedy, so you should check with RaySearch Laboratories to see if a correction is available.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2353-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2353-2020 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.
