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

RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.

Pending LLM rewrite. Source: FDA_DEVICE Z-2491-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

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 — Devices

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.

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