RaySearch Laboratories recalls RayStation software versions 14.0.0.3338 and 15.0.0.430 due to potential duplicate DICOM identifiers, which could cause treatment planning errors in radiation therapy systems.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
RaySearch Laboratories is recalling specific versions of their RayStation radiation therapy software because duplicate DICOM identifiers might cause treatment planning errors. This could lead to incorrect radiation doses being delivered to patients during cancer treatment.
The software may generate duplicate DICOM identifiers, which are unique codes used to track medical images and treatments. If these identifiers are not unique, the system might incorrectly link images or treatments, leading to errors in radiation therapy planning.
Healthcare professionals using RayStation software for radiation therapy planning are most at risk. Patients receiving treatment with these specific software versions could potentially receive incorrect radiation doses.
Check if your RayStation software version is 14.0.0.3338 (UDI: 0735000201055620230630) or 15.0.0.430 (UDI: 0735000201072320231213). The software was sold between 2023 and 2024.
Verify your RayStation software version by checking the version number in the software settings or documentation.
The recall is due to a potential issue where DICOM identifiers are not guaranteed to be unique, which could cause errors in radiation therapy treatment planning.
RayStation 2023B version 14.0.0.3338 and RayStation 2024A version 15.0.0.430 are affected.
The recall record does not specify a fix or remedy for this issue.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2495-2025 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2495-2025 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.
