The Recall Desk
HighFDA (Devices)·Z-2489-2025·Announced 2025-09-10

RayStation Radiation Therapy Planning System DICOM Identifier Collision Risk

RayStation radiation therapy planning software has DICOM identifiers that are not guaranteed to be unique. This could cause patient data attribution errors when interfacing with Accuray's iDMS system.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device recall involves a data integrity issue in a critical treatment planning system where non-unique DICOM identifiers could cause patient data attribution errors. No illnesses or injuries have been reported, but the hazard presents significant risk of harm in a patient safety-critical application, meeting the rubric criterion for High severity.

Plain-English summary

RayStation is a radiation therapy treatment planning system manufactured by RaySearch Laboratories AB. Five software versions are affected: RayStation 9B (version 9.1.0.933), RayStation 9B Service Pack 1 (9.2.0.483), RayStation 10A (10.0.0.1154), RayStation 10A Service Pack 1 (10.0.1.52), and RayStation 10A Service Pack 2 (10.0.2.10). The system is distributed worldwide across multiple US states and countries including Canada, China, Colombia, France, Germany, Japan, and others.

The recall addresses a defect in the DICOM SOP Instance UID and Series Instance UID identifiers created by RayGateway, RayStation's interface to Accuray's integrated Data Management System (iDMS). These identifiers are not guaranteed to be unique, which could allow patient treatment data to become associated with incorrect patient records within the system.

RaySearch Laboratories AB is recalling 26 units of the affected software versions. Healthcare facilities using these versions should contact the manufacturer for updated software versions or patches that ensure DICOM identifier uniqueness.

The recalled product

Product
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning
Hazard
  • non-unique-identifier
  • data-integrity

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 1. Software Version: 9.1.0.933
  • UDI: 0735000201026620191220. 2. Software Version: 9.2.0.483
  • UDI: 0735000201029720200310. 3. Software Version: 10.0.0.1154
  • UDI: 0735000201030320200526. 4. Software Version: 10.0.1.52
  • UDI: 0735000201036520200526. 5. Software Version: 10.0.2.10
  • UDI: 0735000201065520220608. Expiration Date: 2025-06-16

Distribution

Distributed nationwide across the United States.

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