The Recall Desk
HighFDA (Devices)·Z-2492-2025·Announced 2025-09-10

Radiation Therapy Planning System Affected by Non-Unique Data Identifiers

RAYSEARCH's RayStation treatment planning software has a defect where medical imaging data identifiers are not guaranteed to be unique, potentially causing incorrect patient data retrieval. This is an FDA Class II recall affecting facilities in 18 US states and multiple countries.

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 medical device software with a data integrity defect affecting patient identification. No illnesses or injuries are reported. The defect presents a risk of patient data misidentification in radiation therapy, which qualifies as a risk-of-harm situation where injury has not yet been reported.

Plain-English summary

RayStation is a radiation therapy treatment planning system produced by RAYSEARCH LABORATORIES AB. The software is used at medical facilities to design radiation therapy treatments for cancer patients. Multiple versions of RayStation 11B are subject to this recall.

The software has a defect where DICOM SOP Instance UIDs and Series Instance UIDs from RayGateway (the interface to Accuray's iDMS) are not guaranteed to be unique. These identifiers are critical for ensuring that the correct patient imaging data is matched to the correct treatment plan. When identifiers are duplicated, the system could retrieve incorrect patient data, potentially resulting in a wrong patient's treatment plan being applied.

This recall affects six institutions distributed across 18 US states and multiple countries including Canada, China, Colombia, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, Thailand, Turkey, UK, and Ukraine. The affected software versions are RayStation 11B versions 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12, and 12.3.0.119.

Affected healthcare facilities should contact RAYSEARCH LABORATORIES AB for a software update to resolve the data identifier issue.

The recalled product

Product
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Soft
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy / Treatment Planning
Hazard
  • data-integrity
  • patient-data-misidentification

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: 12.0.0.932
  • UDI: 0735000201042620211208. 2. Software Version: 12.1.0.1221
  • UDI: 0735000201049520220312. 3. Software Version: 12.0.3.68
  • UDI: 0735000201050120220422. 4. Software Version: 12.0.4.12
  • UDI: 0735000201060020220620. 5. Software Version: 12.3.0.119
  • UDI: 0735000201057020221222. Expiration Date: 2028-03-20

Distribution

Distributed nationwide across the United States.

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