BEUDAMED
    FDA Enforcement Class II Terminated

    Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.

    Recall: Z-1782-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1782-2017
    Event ID
    64545
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ge Medical Systems Information T
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    February 18, 2013
    Classification Date
    April 11, 2017
    Termination Date
    July 31, 2017
    Address
    540 W Northwest Hwy, N/A, Barrington, IL, 60010-3051, United States

    Description

    Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.

    Reason

    It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.

    Code Info

    Versions 1.0, 1.1, 2.0, 2.1

    Distribution

    Nationwide, Worldwide

    Quantity

    118