RaySearch Laboratories recalls specific RayStation software versions due to potential duplicate DICOM UIDs, 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. The issue involves DICOM SOP Instance UIDs and Series Instance UIDs not being guaranteed unique, which could lead to treatment planning errors if duplicate identifiers are used in radiation therapy systems.
The software may generate duplicate DICOM identifiers, which could cause conflicting treatment plans in radiation therapy systems. This might lead to incorrect radiation doses being delivered to patients if the system misinterprets duplicate identifiers.
Radiation therapy professionals using RayStation software versions 9B (9.1.0.933), 9B Service Pack 1 (9.2.0.483), 10A (10.0.0.1154), and their service packs. Patients receiving radiation therapy through these systems may be at risk of treatment errors.
Check if your RayStation software version matches any of the listed versions: 9B (9.1.0.933), 9B Service Pack 1 (9.2.0.483), 10A (10.0.0.1154), or their service packs. The UDI codes provided in the recall are also unique identifiers for these versions.
Identify your RayStation software version by checking the version number in the software interface or documentation.
Reach out to RaySearch Laboratories directly for guidance on whether your version is affected and what steps to take next.
The recall is for the software used in radiation therapy planning systems. Patients may be at risk of treatment errors if the software generates duplicate identifiers, but the manufacturer has not specified a direct patient impact.
Check if your RayStation software version matches any of the listed versions: 9B (9.1.0.933), 9B Service Pack 1 (9.2.0.483), 10A (10.0.0.1154), or their service packs.
Contact RaySearch Laboratories directly for guidance on whether your version is affected and what steps to take next.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2489-2025 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2489-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
