BEUDAMED
    FDA Recall 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 · Initiated October 3, 2016

    Recall

    Recall Number
    Z-0369-2017
    Event Number
    75510
    Firm
    Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland
    FEI Number
    3010208539
    Product Code
    KGI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 3, 2016
    Posted
    November 5, 2016
    Terminated
    June 7, 2017

    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.

    Action

    Medimaps sent an Urgent Field Safety Notice letter dated October 3, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken.

    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