RaySearch Laboratories recalls specific RayStation software versions due to potential for reported SSD values to be too high, which could affect radiation therapy treatment accuracy.
Potential for reported SSD to be too high.
RaySearch Laboratories is recalling several versions of their RayStation radiation therapy software. The recall is because these versions might report an SSD (source-to-surface distance) that's too high, which could lead to inaccurate radiation treatment planning.
The software versions may report an SSD value that is higher than it should be. This could cause radiation treatment plans to be less accurate, potentially affecting patient safety during radiation therapy procedures.
Healthcare professionals using RaySearch RayStation software for radiation therapy planning are affected. Those who have the specific software versions listed in the recall are most at risk.
Check if your RayStation software version is 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12, or 12.3.0.119. The software was sold between 2021 and 2028.
Review your RayStation software version to see if it matches the recalled versions listed in the recall notice.
Reach out to RaySearch Laboratories for guidance on next steps if you have the recalled software versions.
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12, and 12.3.0.119.
The recalled versions may report an SSD (source-to-surface distance) that is too high, which could lead to inaccurate radiation treatment planning.
The recall does not require immediate stop use; healthcare professionals should check their version and contact RaySearch Laboratories for guidance.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1749-2024 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1749-2024 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.