The Recall Desk
HighFDA (Devices)·Z-2488-2025·Announced 2025-09-10

RayStation Radiation Therapy Software: Non-Unique Medical Image Identifiers

Multiple versions of RayStation, a radiation therapy treatment planning system, are being recalled due to non-unique DICOM identifiers in the RayGateway interface, which could lead to image mix-ups 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 a Class II FDA-classified medical device recall involving a risk-of-harm product. The non-uniqueness of medical image identifiers in a radiation therapy planning system poses a clear potential for patient safety issues through image mix-ups, though no injuries or illnesses have been reported in the source material.

Plain-English summary

RaySearch Labs AB has recalled multiple versions of RayStation, a radiation therapy treatment planning system used worldwide. The affected versions include RayStation 8B (versions 8.1.0.47, 8.1.1.8, and 8.1.2.5) and RayStation 9A (versions 9.0.0.113 and 9.0.1.142).

The issue involves the RayGateway interface, which connects to Accuray's imaging management system. DICOM SOP Instance UID and Series Instance UID values from RayGateway are not guaranteed to be unique. These identifiers are critical for ensuring medical images are correctly associated with the right patient and treatment plan during radiation therapy planning.

The product has been distributed worldwide, including throughout the United States and internationally to Canada, China, Colombia, France, Germany, Hong Kong, Italy, Japan, the Netherlands, Poland, Spain, Sweden, Switzerland, Thailand, Turkey, the United Kingdom, and Ukraine.

Healthcare facilities using affected RayStation versions should contact RaySearch Labs AB for information regarding this recall and any necessary software updates or corrections.

The recalled product

Product
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Treatment Planning
Hazard
  • data-integrity
  • identifier-confusion
  • image-mix-up

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: 8.1.0.47
  • UDI: 0735000201012920181209. 2. Software Version: 8.1.1.8
  • UDI: 0735000201020420190214. 3. Software Version: 8.1.2.5
  • UDI: 0735000201023520190524. 4. Software Version: 9.0.0.113
  • UDI: 0735000201017420190612. 5. Software Version: 9.0.1.142
  • UDI: 0735000201048820220420. Expiration Date: 2027-12-15

Distribution

Distributed nationwide across the United States.

Related recalls

Same category