BEUDAMED
    FDA Recall 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 · Initiated February 23, 2015

    Recall

    Recall Number
    Z-2100-2017
    Event Number
    77177
    Firm
    Mobius Medical Systems, LP
    FEI Number
    3008610750
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 23, 2015
    Posted
    May 16, 2017
    Terminated
    July 10, 2017
    Address
    4615 Southwest Fwy, Ste 330, Houston, TX, 77027-7106

    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.

    Action

    The recalling firm sent an Advisory Notice letter dated February 23, 2015 to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Mobius Medical Systems Customer Support at [email protected].

    Distribution

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

    Quantity

    270