The Recall Desk
HighFDA (Devices)·Z-2494-2025·Announced 2025-09-10

RayStation Radiation Therapy Software Faces Unique Patient Data Identifier Issue

RayStation radiation therapy treatment planning software may not guarantee unique identifiers for patient images, potentially leading to data mix-up during treatment planning.

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 an FDA Class II recall involving a radiation therapy treatment planning system with a data integrity defect creating theoretical risk of patient data mix-up. No injuries or illnesses have been reported. Per the rubric, recalls with risk-of-harm products where no injuries have been reported score at most 3 (High).

Plain-English summary

RayStation is a radiation therapy treatment planning system used to prepare and optimize cancer radiation treatments. The software versions affected include 6.1.1.2, 6.2.0.7, and 6.3.0.6.

The software has a data integrity issue: DICOM SOP Instance UID and Series Instance UID from RayGateway (the interface to Accuray's iDMS system) are not guaranteed to be unique. This means two different patient images could potentially receive the same unique identifier, which could lead to patient data confusion or treatment plan mix-ups during the treatment planning process.

This issue affects facilities using the affected software versions across the United States and internationally, including Canada, China, Colombia, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, and the United Kingdom.

Users of RayStation software should contact RaySearch Laboratories AB for information about available software updates and patches to resolve this data integrity issue.

The recalled product

Product
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Thera
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Treatment Planning
Hazard
  • data-integrity
  • patient-identification-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: 6.1.1.2
  • UDI: 0735000201008220170529. 2. Software Version: 6.2.0.7
  • UDI: 0735000201007520170630. 3. Software Version: 6.3.0.6
  • UDI: 0735000201024220190923. Expiration Date: 2024-10-18

Distribution

Distributed nationwide across the United States.

Related recalls

Same category