BEUDAMED
    FDA Enforcement Class II Terminated

    Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.

    Recall: Z-2100-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2100-2017
    Event ID
    77177
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mobius Medical Systems, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    February 23, 2015
    Classification Date
    May 16, 2017
    Termination Date
    July 10, 2017
    Address
    4615 Southwest Fwy Ste 330, Houston, TX, 77027-7106, United States

    Description

    Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.

    Reason

    Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam customization, and may lead to a discrepancy in dose calculation between this version of Mobius3D (1.5.0) and the prior version (1.4.2), where none should have been expected.

    Code Info

    Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France

    Quantity

    270