BEUDAMED
    FDA Enforcement Class II Terminated

    AIRO Mobile CT System Model # MobiCT-32

    Recall: Z-2991-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-2991-2018
    Event ID
    80867
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mobius Imaging, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    September 26, 2018
    Initiation Date
    August 1, 2018
    Classification Date
    September 14, 2018
    Termination Date
    December 13, 2019
    Address
    2 Shaker Rd Ste F100, N/A, Shirley, MA, 01464-2535, United States

    Description

    AIRO Mobile CT System Model # MobiCT-32

    Reason

    The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed.

    Code Info

    Model # MobiCT-32

    Distribution

    US and foreign distribution.

    Quantity

    147