Reported Mar 16, 2022 · Ongoing

RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 ,…

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/RayPlan- designed for treatment planning and analysis of radiation therapy
  • Software Version
    • 6.0.0.24
    • 6.1.0.26
    • 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
  • Including Service PaksProduct name (build number) UDI-DI RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013 RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082 RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075 RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242 RayStation/RayPlan 7 (7.0.0.19) 07350002010068 RayStation/RayPlan 8A (8.0.0.61) 07350002010112 RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136 RayStation/RayPlan 8B (8.1.0.47) 07350002010129 RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204 RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235 RayStation/RayPlan 9A (9.0.0.113) 07350002010174 RayStation/RayPlan 9B (9.1.0.933) 07350002010266 RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297
Lot codes and dates
  • Software
    • 6.0.0.24
    • 6.1.0.26
    • 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
  • UDI
    • 07350002010013
    • 07350002010082
    • 07350002010075
    • 07350002010242
    • 07350002010068
    • 07350002010112
    • 07350002010136
    • 07350002010129
    • 07350002010204
    • 07350002010235
    • 07350002010174
    • 07350002010266
    • 07350002010297
    • 07350002010013
    • 07350002010082
    • 07350002010075
    • 07350002010242
    • 07350002010068
Amount recalled
75 Licenses

Where it was sold

  • Nationwide

Why it was recalled

If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running

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, 5:34 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.