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.
Potential for reported SSD to be too high.
RaySearch Laboratories is recalling two versions of their radiation therapy software (RayStation 10.1.0.613 and 10.1.1.54) because they may report safety distances too high, potentially leading to inaccurate radiation treatments. This could affect patient safety during cancer therapy.
The software may report a safety distance (SSD) that is higher than it should be. This could lead to radiation being delivered to areas of the body that should be protected, 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 reports incorrect safety distances.
Check for software version numbers 10.1.0.613 or 10.1.1.54. The software was sold with specific UDI and GTIN codes listed in the recall notice.
Identify the software version by checking the version numbers on your system.
The recall states there is a potential for reported safety distances to be too high, which could affect treatment accuracy. However, the hazard is described as low risk.
Check your software version. If it is 10.1.0.613 or 10.1.1.54, contact RaySearch Laboratories for guidance.
Look for the version numbers 10.1.0.613 or 10.1.1.54 in your software settings or documentation.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1747-2024 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1747-2024 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.
