RaySearch Laboratories recalls RayStation software versions 8.1.0.47 and 9.0.0.113 due to potential duplicate DICOM identifiers, which could cause treatment 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 errors. This affects medical professionals using these software versions for radiation therapy planning.
The software may generate duplicate DICOM identifiers, which are critical for tracking radiation therapy treatments. If duplicates occur, it could lead to incorrect treatment planning or patient safety issues in radiation therapy systems.
Medical professionals who use RayStation software versions 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, or 9.0.1.142 for radiation therapy planning are most at risk. These software versions were sold with specific unique identifiers (UDIs) that may not be unique.
Check if your RayStation software version matches the listed versions: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, or 9.0.1.142. The unique identifiers (UDIs) provided in the recall list may help identify affected units.
Review your RayStation software version to see if it matches the recalled versions: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, or 9.0.1.142.
The recall is due to potential duplicate DICOM identifiers, which could cause treatment errors in radiation therapy systems.
Check your software version against the listed versions. If affected, contact RaySearch Laboratories for further instructions.
The recall record does not specify a remedy or fix 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-2488-2025 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2488-2025 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.