Reported Jul 27, 2022 · Terminated

RayStation 9B SP1. For radiation treatment planning.

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 · Sveavagen 9 · Stockholm, N/A · N/A

Is this the product you have?

  • RayStation 9B SP1. For radiation treatment planning.
Lot codes and dates
  • UDI-DI0735000201029720200310 Build number 9.2.0.483
Amount recalled
1

Where it was sold

  • Nationwide
  • TN

Why it was recalled

An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.

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

Notice updated Oct 4, 2023 · 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.