BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System

    Recall: Z-0761-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0761-2013
    Event ID
    64226
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2013
    Initiation Date
    August 3, 2012
    Classification Date
    February 26, 2013
    Termination Date
    December 5, 2013
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System

    Reason

    GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.

    Code Info

    Model Number : 5271997

    Distribution

    Nationwide Distribution including NM, WY, FL, MO, MA, and MI.

    Quantity

    9 units installed in US