Reported May 8, 2024 · Ongoing

RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.

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

Is this the product you have?

  • RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Lot codes and dates
  • UDI0735000201030320200526, 0735000201036520200526 and 0735000201065520220608
  • GTIN
    • 07350002010303
    • 07350002010365 and 07350002010655
  • Serial Numbers
    • 10.0.0.1154
    • 10.0.1.52 and 10.0.2.10
  • Expiration Date2025-06-16
Amount recalled
213 units

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

  • Nationwide

Why it was recalled

Potential for reported SSD to be too high.

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, 6:56 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.