The Recall Desk
HighFDA (Devices)·Z-2490-2025·Announced 2025-09-10

RayStation radiation therapy software versions have non-unique DICOM identifiers

RayStation radiation therapy software versions 10.1.0.613 and 10.1.1.54 may have non-unique DICOM identifiers affecting treatment planning data integrity. The recall covers 3 units distributed across the US and internationally.

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: FDA Class II classification with potential to compromise patient treatment data integrity through non-unique DICOM identifiers. No reported illnesses, injuries, or hospitalizations, so per the rubric the score is at most 3 (High) for a risk-of-harm medical device issue without reported adverse events.

Plain-English summary

RayStation is a radiation therapy treatment planning system manufactured by RaySearch Laboratories AB. Versions 10.1.0.613 and 10.1.1.54 are subject to this FDA Class II recall.

The affected software may generate non-unique DICOM SOP Instance UIDs and Series Instance UIDs through the RayGateway interface, which connects to Accuray's iDMS system. Non-unique identifiers could compromise the integrity and traceability of patient treatment planning data.

This recall affects 3 units distributed worldwide, including facilities across multiple US states (Alabama, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, New York, North Carolina, Ohio, Oklahoma, South Carolina, Washington, and Wisconsin) and numerous countries (Canada, China, Colombia, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, England, Thailand, Turkey, United Kingdom, and Ukraine).

The recalled product

Product
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning
Hazard
  • dicom-uid-duplication
  • treatment-planning-error

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 (3)

  • 1. Software Version: 10.1.0.613
  • UDI: 0735000201031020201216. 2. Software Version: 10.1.1.54
  • UDI: 0735000201047120220128. Expiration Date: 2027-02-01

Distribution

Distributed nationwide across the United States.

Related recalls

Same category