The Recall Desk
HighFDA (Devices)·Z-2491-2025·Announced 2025-09-10

RayStation Radiation Therapy Planning System Affected by Non-unique Identifier Issue

RayStation radiation therapy planning software is being recalled because DICOM identifiers are not guaranteed to be unique, potentially affecting data integrity. This FDA Class II recall applies to 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: This is a risk-of-harm product (radiation therapy planning system) where no injuries have been reported. The technical issue involves non-unique system identifiers that could affect data integrity, classified as FDA Class II with no reported hospitalization or patient harm.

Plain-English summary

RaySearch Laboratories AB is recalling RayStation, a radiation therapy treatment planning system, due to a technical issue affecting data integrity. The problem involves DICOM SOP Instance UID and Series Instance UID from RayGateway—the interface to Accuray's imaging management system—which are not guaranteed to be unique.

Affected versions include RayStation 11A (Software Version 11.0.0.951), RayStation 11A Service Pack 1 (11.0.1.29), RayStation 11A Service Pack 2 (11.0.3.116), and RayStation 11A Service Pack 3 (11.0.4.15). The recall applies to units distributed in multiple US states and countries, including Canada, China, Colombia, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, England, Thailand, Turkey, UK, and Ukraine.

Non-unique identifiers in a medical imaging system could potentially lead to data integrity issues. Healthcare facilities using affected versions of RayStation should contact RaySearch Laboratories AB for guidance on remediation options and software updates.

The recalled product

Product
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Softw
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning Software
Hazard
  • data-integrity
  • system-identifier-collision

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 (5)

  • 1. Software Version: 11.0.0.951
  • UDI: 0735000201038920210518. 2. Software Version: 11.0.1.29
  • UDI: 0735000201043320210610. 3. Software Version: 11.0.3.116
  • UDI: 0735000201044020210916. 4. Software Version: 11.0.4.15
  • UDI: 0735000201063120220616. Expiration Date: 2027-06-22

Distribution

Distributed nationwide across the United States.

Related recalls

Same category