BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0761-2013 · Initiated August 3, 2012

    Recall

    Recall Number
    Z-0761-2013
    Event Number
    64226
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    JAC
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 3, 2012
    Posted
    February 26, 2013
    Terminated
    December 5, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    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.

    Action

    GE Healthcare will, without charge, remedy the issue or bring the product into compliance with each applicable Federal and IEC standard in accordance with a planto be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the software on the system to address the issue. Contact Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification

    Distribution

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

    Quantity

    9 units installed in US