BEUDAMED
    FDA Enforcement Class II Ongoing

    MICRO-X Rover Mobile X-ray System, # MXU-RV19

    Recall: Z-0666-2025 · Reported December 18, 2024

    Enforcement

    Recall Number
    Z-0666-2025
    Event ID
    95593
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Micro-X Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2024
    Initiation Date
    October 23, 2024
    Classification Date
    December 12, 2024
    Address
    Unit 14 6 Mab Eastern Promenade, Tonsley, N/A, Australia

    Description

    MICRO-X Rover Mobile X-ray System, # MXU-RV19

    Reason

    During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.

    Code Info

    UDI-DI: 09357123000013. Serial Numbers: 262, 274, 320, 329, 237, 269, 271, 290, 292, 307, 310, 311, 312, 321, 322, 323, 327, 330, 331, 332, 333, 234, 266.

    Distribution

    US Nationwide Distribution: TX, CA, OH, ID, WA, AZ

    Quantity

    23