BEUDAMED
    FDA Recall Terminated

    AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).

    Recall: Z-0509-2018 · Initiated July 28, 2017

    Recall

    Recall Number
    Z-0509-2018
    Event Number
    79009
    Firm
    Brainlab AG Olof-Palme-Strasse 9 Munich Germany
    FEI Number
    3010151377
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 28, 2017
    Terminated
    July 25, 2018

    Description

    AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).

    Reason

    Risk of unintended motion while the AIRO system is in transport mode.

    Action

    AIRO customers were issued Field Safety Notices dated June 29, 2017. The letter identified the affected product, problem and actions to be taken. A warning label was provided to be placed on the system. For questions contact your local Brainlab Customer Support Representative.

    Distribution

    Worldwide Distribution - US Nationwide in the U.S. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV; and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and Uzbekistan.

    Quantity

    102