RaySearch Laboratories recalls RayStation 6 Service Pack 2 (UDI #07350002010075) due to potential underestimation of radiation dose in cancer treatment calculations.
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 2 software updates for radiation therapy systems. This update could cause the software to underestimate radiation doses during cancer treatment, potentially affecting treatment accuracy.
The software contains an error in dose calculation algorithms that might cause the system to underestimate the radiation dose delivered to tumors. This could lead to under-treatment of cancer in some cases, though the risk is not immediate or severe in normal use.
Medical professionals using RayStation 6 Service Pack 2 for radiation therapy or cancer treatment. Patients receiving radiation therapy with this software may be at risk if the dose calculation is inaccurate.
Check if your RayStation 6 software has build number 6.2.0.7. The recall applies to units with UDI # 07350002010075 used in radiation therapy and medical oncology.
Verify your RayStation 6 software build number is 6.2.0.7 to determine if it's affected.
The recall indicates a potential software error that could cause underestimation of radiation dose, but it does not state that the error causes immediate harm or serious injury.
Check for build number 6.2.0.7 with UDI # 07350002010075 in your RayStation 6 software.
The recall does not specify a stop-use action; users should check their software version to see if they need to update.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2342-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2342-2020 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.
