BEUDAMED
    FDA Enforcement Class II 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-0715-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0715-2018
    Event ID
    79159
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mobius Imaging, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 7, 2018
    Initiation Date
    September 26, 2017
    Classification Date
    February 23, 2018
    Termination Date
    August 16, 2018
    Address
    2 Shaker Rd Ste F100, N/A, Shirley, MA, 01464-2535, United States

    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

    If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan.

    Code Info

    Requested.

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, NC, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Pakistan, Russia, Saudi Arabia, Spain, Switzerland, UAE, Uzebekistan

    Quantity

    105