Reported Sep 10, 2025 · Ongoing

RayStation with the following product descriptions

Raysearch Laboratories Ab

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: RAYSEARCH LABORATORIES AB · Eugeniavagen 18c · Stockholm, N/A · N/A

Is this the product you have?

RayStation with the following product descriptions

3 of 3 products

Products covered by this recall
#Product as published
1RayStation 7, Software Version: 7.0.0.19.
2RayStation 8A, Software Version: 8.0.0.61.
3RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning System.
Lot codes and dates
  • 1
  • Software Version7.0.0.19
  • UDI0735000201006820171130. 2
  • Software Version8.0.0.61
  • UDI0735000201011220180608. 3
  • Software Version8.0.1.10
  • UDI0735000201013620180928
  • Expiration Date2023-10-04
Amount recalled
1

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.