The Recall Desk
HighFDA (Devices)·Z-2493-2025·Announced 2025-09-10

RayStation Radiation Therapy Software Recalled for Data Integrity Issue

RayStation radiation therapy planning software by RaySearch Laboratories AB has been recalled due to a data integrity issue where DICOM instance identifiers are not guaranteed to be unique, potentially affecting treatment plan accuracy.

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 Class II recall involves a radiation therapy planning system with a data integrity issue where DICOM identifiers are not guaranteed to be unique. This represents a risk-of-harm product where treatment planning errors could potentially occur; however, no reported injuries or illnesses are documented in the source material.

Plain-English summary

RayStation is a radiation therapy treatment planning system developed by RaySearch Laboratories AB. The recalled versions include RayStation 12A (Software Version 13.0.0.1547), RayStation 12A Service Pack 1 (Software Version 13.1.0.144), and RayStation 12A Service Pack 2 (Software Version 13.1.1.89).

The FDA has determined that DICOM SOP Instance UIDs and Series Instance UIDs from RayGateway—the interface to Accuray's iDMS system—are not guaranteed to be unique. This data integrity issue could potentially affect the accuracy and consistency of radiation therapy treatment plans.

Thirteen units of this software have been distributed worldwide, including to medical facilities in the United States (Alabama, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, New York, North Carolina, Ohio, Oklahoma, South Carolina, Washington, and Wisconsin), Canada, China, Colombia, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, England, Thailand, Turkey, United Kingdom, and Ukraine.

Healthcare facilities using this software should contact RaySearch Laboratories AB for guidance on the appropriate corrective action or update. Users should verify the software version in use matches one of the recalled versions identified in this notice.

The recalled product

Product
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Thera
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Treatment Planning Software
Hazard
  • data-integrity
  • treatment-error-risk

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 (4)

  • 1. Software Version: 13.0.0.1547
  • UDI: 0735000201054920220616. 2. Software Version: 13.1.0.144
  • UDI: 0735000201067920221007. 3. Software Version: 13.1.1.89
  • UDI: 0735000201073020230913. Expiration Date: 2028-07-07

Distribution

Distributed nationwide across the United States.

Related recalls

Same category