RaySearch Laboratories recalls RayStation software versions 7.0.0.19 and 8.0.0.61 due to potential duplicate DICOM identifiers, which could cause treatment planning errors in radiation therapy. Affected users should contact the company for details.
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 the DICOM identifiers used in the system might not be unique. This could lead to errors in treatment planning if the software is used without proper identification. The recall affects users who have the specified software versions.
The software may generate duplicate DICOM identifiers, which are used to track medical images and treatment plans. If these identifiers are not unique, it could cause confusion or errors in radiation therapy planning. However, the risk is not described as causing immediate harm or serious injury.
Healthcare professionals using RayStation software for radiation therapy planning are most at risk. The recall applies to users with the specific software versions listed in the notice.
Check if your RayStation software version is 7.0.0.19 or 8.0.0.61 (with the specified UDI numbers). The recall also includes Service Pack 1 version 8.0.1.10. These versions were sold between 2017 and 2018.
Review your RayStation software version to see if it matches the recalled versions: 7.0.0.19, 8.0.0.61, or 8.0.1.10.
RayStation 7 version 7.0.0.19, RayStation 8A version 8.0.0.61, and RayStation 8A Service Pack 1 version 8.0.1.10.
The recall states that duplicate DICOM identifiers could cause treatment planning errors, but it does not mention a risk of serious injury or death.
The recall does not specify a remedy; users are advised to check their software version and contact RaySearch Laboratories for further details.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2487-2025 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2487-2025 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.