RaySearch Laboratories recalls RayStation 10B software versions 10.1.0.613 and 10.1.1.54 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. This recall is due to a potential issue where DICOM identifiers might not be unique, which could lead to treatment planning errors in radiation therapy systems.
The software may generate duplicate DICOM identifiers (UIDs) which are used to track medical images and treatment plans. If these identifiers are not unique, it could cause confusion in the treatment planning system, potentially leading to incorrect radiation doses being delivered to patients.
Radiation therapy professionals using RayStation software versions 10.1.0.613 and 10.1.1.54 are affected. Patients receiving radiation therapy through these systems may be at risk of treatment errors.
Check if your RayStation software version is 10.1.0.613 (UDI: 0735000201031020201216) or 10.1.1.54 (UDI: 0735000201047120220128). These versions were sold between 2012 and 2027.
Verify your RayStation software version by checking the version number in the software interface or documentation.
The recall is due to a potential issue where DICOM identifiers might not be unique, which could cause treatment planning errors in radiation therapy systems.
RayStation 10B software versions 10.1.0.613 (UDI: 0735000201031020201216) and 10.1.1.54 (UDI: 0735000201047120220128) are affected.
Check your software version in the RayStation interface or documentation. Affected versions were sold between 2012 and 2027.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2490-2025 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2490-2025 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.
