RaySearch Laboratories recalls RayStation 9B Service Pack 1 software update (UDI #07350002010297) due to potential underestimation of radiation dose in cancer treatment. Affected users should contact the manufacturer for a fix.
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 9B Service Pack 1 software updates that could underestimate radiation doses during cancer treatment. This error might lead to inadequate radiation delivery, potentially affecting treatment outcomes.
The software error in dose calculation algorithms could cause the system to underestimate the radiation dose delivered to tumors. This might result in insufficient radiation being administered, potentially reducing treatment effectiveness.
Medical professionals using RayStation 9B for radiation therapy or medical oncology treatments are affected. Patients receiving these treatments may be at risk if the software error impacts dose accuracy.
Check if your RayStation 9B software version is 9.2.0.483 with UDI #07350002010297. The product is used for radiation therapy and medical oncology treatments.
Reach out to RaySearch Laboratories for guidance on the software update and potential fixes.
The software error could lead to underestimated radiation doses during cancer treatment, potentially affecting treatment effectiveness. However, it does not cause immediate injury.
Check if your RayStation 9B software version is 9.2.0.483 with UDI #07350002010297.
No immediate stop is required. Contact RaySearch Laboratories for guidance on the fix.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2351-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2351-2020 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.
