BEUDAMED
    FDA Recall Terminated

    AIRO Mobile CT System Model # MobiCT-32

    Recall: Z-2991-2018 · Initiated August 1, 2018

    Recall

    Recall Number
    Z-2991-2018
    Event Number
    80867
    Firm
    Mobius Imaging, LLC
    FEI Number
    3010151377
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 1, 2018
    Terminated
    December 13, 2019
    Address
    2 Shaker Rd, Ste F100, Shirley, MA, 01464-2535

    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.

    Action

    Mobius Imaging, LLC sent an URGENT MEDICAL DEVICE RECALL letter to customers advising that a voluntary recall related to the AIRO Mobile CT System was initiated. The letter included the reason for the recall and actions to be taken by the customers.

    Distribution

    US and foreign distribution.

    Quantity

    147