Reported Nov 7, 2018 · Terminated

RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software 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 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Lot codes and dates
  • Software
  • include version number
    • 4.5.0.19
    • 4.5.1.14
    • 4.5.2.7
    • 4.7.0.15
    • 4.7.1.10
    • 4.7.2.5
    • 4.7.3.13
    • 4.7.4.4
    • 4.7.5.4
    • 5.0.0.37
    • 5.0.1.11
    • 5.0.2.3
    • 6.0.0.24
    • 6.1.0.26
    • 6.1.1.2
    • 6.2.0.7
    • 7.0.0.19
Amount recalled
110 units

Where it was sold

  • Nationwide

Why it was recalled

Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.

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 Jun 16, 2020 · Data as of Sep 19, 5:33 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.