Reported Dec 2, 2020 · Terminated

RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0,…

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 standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 -
  • Product UsageRayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs
Lot codes and dates
  • Software version numbers
    • 4.0.0.14
    • 4.0.3.4
    • 4.5.1.14
    • 4.7.2.5
    • 4.7.3.13
    • 4.7.4.4
    • 4.7.5.4
    • 4.7.6.7
    • 4.9.0.42
    • 5.0.1.11
    • 5.0.2.35
    • 5.0.3.17
    • 6.0.0.24
    • 6.1.1.2
    • 6.2.0.7
    • 6.3.0.6
    • 7.0.0.19
    • 8.0.0.61
    • 8.0.1.10
    • 8.1.0.47
    • 8.1.1.8 8.1.2.5
    • 9.0.0.113
    • 9.1.0.933
    • 9.2.0.483
    • 10.0.0.1154
Amount recalled
2768

Where it was sold

  • Nationwide

Why it was recalled

If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.

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 Mar 30, 2023 · Data as of Sep 19, 4:54 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.