RayStation Radiation Therapy Software DICOM Instance Identifier Uniqueness Issue
RayStation radiation therapy planning software versions 2023B, 2024A, and 2024A SP3 have a data integrity issue where DICOM instance identifiers may not be unique, potentially mixing patient imaging data. Contact RaySearch Laboratories for guidance.
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 medical device where potential injury has not yet been reported. The data integrity issue could lead to serious patient harm if imaging data is incorrectly matched to wrong patients in radiation therapy planning. No hospitalizations, 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 recall affects RayStation software versions 2023B (Software Version 14.0.0.3338), 2024A (Software Version 15.0.0.430), and 2024A SP3 (Software Version 15.1.3.10), affecting 49 installations.
The software has a critical data integrity issue: DICOM Service-Object Pair (SOP) Instance UIDs and Series Instance UIDs received from RayGateway—the interface to Accuray's imaging data management system—are not guaranteed to be unique. In radiation therapy planning, unique identifiers are essential to ensure that patient imaging data is correctly matched and linked to treatment plans. Non-unique identifiers could result in imaging data from one patient being associated with another patient's treatment plan.
The affected software is distributed worldwide, including across 18 U.S. states and multiple countries including Canada, China, Colombia, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, England, Thailand, Turkey, United Kingdom, and Ukraine.
Users operating RayStation with these affected versions should immediately contact RaySearch Laboratories AB for a software update or mitigation guidance to ensure patient safety and data integrity.
The recalled product
- Product
- RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Plannin
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- data-integrity
- patient-data-mismatch
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: 14.0.0.3338
- UDI: 0735000201055620230630. 2. Software Version: 15.0.0.430
- UDI: 0735000201072320231213. 3. Software Version: 15.1.3.10
- UDI: 0735000201087720241106. Expiration Date: 2030-02-21
Distribution
Distributed nationwide across the United States.
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