BEUDAMED
    FDA Recall Terminated

    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx

    Recall: Z-1405-2015 · Initiated December 19, 2014

    Recall

    Recall Number
    Z-1405-2015
    Event Number
    70924
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    December 19, 2014
    Posted
    April 27, 2015
    Terminated
    April 29, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx

    Reason

    An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.

    Action

    GE Healthcare planned action: 1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX. 2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance. 3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on how to perform a mAs accuracy check and how to determine if the test results pass predetermined acceptance criteria. If you have any questions or concerns regarding this notification, please call the Information following phone number: 1-800-437-1171.

    Distribution

    US Distribution to the states of: AZ, FL, GA, MO and WI.

    Quantity

    6 units US