RaySearch Laboratories recalls specific versions of their radiation therapy software due to potential for reported SSD (safety distance) values to be too high, which could affect treatment accuracy. Affected versions include 8.1.0.47, 8.1.1.8, and 8.1.2.5 with serial numbers starting with 8.0.0.61 or 8.0.1.10.
Potential for reported SSD to be too high.
RaySearch Laboratories is recalling specific versions of their radiation therapy software (RayStation 8.1.0.47, 8.1.1.8, and 8.1.2.5) because there's a potential for reported SSD values to be too high. This could lead to inaccurate radiation treatments if not corrected.
The software may report an incorrect safety distance (SSD) value, which is critical for precise radiation targeting. If the reported SSD is too high, radiation doses could be delivered to unintended areas, potentially affecting treatment accuracy and patient safety.
Healthcare professionals using RaySearch's radiation therapy software for cancer treatment planning. Patients receiving radiation therapy through this system may be at risk if the software is not updated.
Check for software versions 8.1.0.47, 8.1.1.8, or 8.1.2.5. Look for serial numbers starting with 8.0.0.61 or 8.0.1.10. The software was sold with specific expiration dates and unique identifiers.
Identify your RayStation version by checking the software settings or documentation.
Contact RaySearch Laboratories to update to a newer version that addresses the SSD issue.
RayStation 8.1.0.47, 8.1.1.8, and 8.1.2.5 are affected.
Check for serial numbers starting with 8.0.0.61 or 8.0.1.10, or software versions 8.1.0.47, 8.1.1.8, or 8.1.2.5.
The recall is for potential inaccuracies in SSD values, which could affect treatment precision but does not indicate a risk of serious injury in normal use.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1743-2024 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1743-2024 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.