BEUDAMED
    FDA Enforcement Class II Terminated

    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

    Recall: Z-0369-2017 · Reported November 16, 2016

    Enforcement

    Recall Number
    Z-0369-2017
    Event ID
    75510
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medimaps Group
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 16, 2016
    Initiation Date
    October 3, 2016
    Classification Date
    November 5, 2016
    Termination Date
    June 7, 2017
    Address
    Fongit, Chemin des Aulx 18, Plan-les-Ouates, N/A, Switzerland

    Description

    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

    Reason

    The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.

    Code Info

    Version v.3.0.1; Serial # 14295, 300409, 70580, 200042, 500581, 70103, 70174, 80936, 100202, 201120, 84584, 83769, 100112, 210020, 210440

    Distribution

    Worldwide Distribution - US Nationwide - in the states of: IL, NC, CA, DE, NY, MD, WI, MN. And the following countries: France,Thailand, Croatia, Canada, Italy, Spain, Russian Federation, Ukraine, Lithuania, South Africa, Brazil, Lebanon, Saudi Arabia, Korea, China Portugalm Iraq, Syrian Arab Republic, Czech Republic, Australia, Belgium, Austria, Romania, New Zealand, Switzerland, Hong Kong, Sweden, Mexico, Islamic Republic of Iran, Serbia, Netherlands, Denmark, and UK.

    Quantity

    15 units in US