BEUDAMED
    FDA Recall Terminated

    Brivo XR385, model 5215463, Digital Diagnostic Radiographic System

    Recall: Z-2523-2018 · Initiated September 16, 2016

    Recall

    Recall Number
    Z-2523-2018
    Event Number
    80486
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    September 16, 2016
    Posted
    July 16, 2018
    Terminated
    July 26, 2018
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Brivo XR385, model 5215463, Digital Diagnostic Radiographic System

    Reason

    The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.

    Action

    An Important Electronic Product Radiation Warning letter was sent to consignees beginning 9/16/2016. The letter identified affected product, described the issue, and stated that GE will correct the devices without charge. Questions can be directed to 1-800-437-1171.

    Distribution

    AK, AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MS, NJ, NM, OR, PA, TN, TX, VA, and Guam, and Canada.

    Quantity

    58 (55 US, 3 OUS)