RaySearch Laboratories recalls software version 8.1.1.8 for potential incorrect treatment planning calculations. Users should contact the company for updates.
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
RaySearch Laboratories is recalling a specific software update for radiation treatment planning systems. This update could cause incorrect positioning calculations during treatment, which might affect patient safety.
The software update may incorrectly calculate the patient's position during radiation treatment. This could lead to inaccurate treatment delivery if pitch or roll corrections are applied, though the correction itself is not propagated.
Medical professionals using RayStation or RayPlan software for radiation treatment planning systems. Those with the specific software version 8.1.1.8 are most at risk.
Check if you have RayStation or RayPlan software version 8B Service Pack 1, Build Number 8.1.1.8. The unique device identifier (UDI) is 07350002010204.
Reach out to RaySearch Laboratories for guidance on the software update and potential fixes.
The recall indicates a potential for incorrect treatment planning calculations, but the exact risk level is not specified in the notice.
Contact RaySearch Laboratories directly for instructions on the next steps.
Look for the software version 8B Service Pack 1, Build Number 8.1.1.8 with UDI 07350002010204.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1465-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1465-2020 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.