BEUDAMED
    FDA Recall Terminated

    AMX Navigate Mobile X-Ray System

    Recall: Z-2590-2021 · Initiated June 24, 2021

    Recall

    Recall Number
    Z-2590-2021
    Event Number
    88601
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 24, 2021
    Posted
    September 29, 2021
    Terminated
    June 14, 2023
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    AMX Navigate Mobile X-Ray System

    Reason

    An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.

    Action

    On June 24, 2021 the firm contacted the facilities that received the device via email. An AMX Navigate system was provided to 3 healthcare facilities for evaluation under an agreement with GE Healthcare. While at the healthcare facilities, these systems remained under the ownership of GE Healthcare. After one of the healthcare facilities alerted GE Healthcare to a potential issue with its system, GE Healthcare removed the system from the 3 healthcare facilities in order to perform a detailed engineering analysis as part of its root cause investigation. These 3 systems have not been returned to the healthcare facilities and remain in GE Healthcare s possession.

    Distribution

    Domestic Distribution Only

    Quantity

    3 units