BEUDAMED
    FDA Enforcement Class II Terminated

    Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.

    Recall: Z-0195-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0195-2019
    Event ID
    81297
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2018
    Initiation Date
    August 30, 2018
    Classification Date
    October 18, 2018
    Termination Date
    August 31, 2022
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.

    Reason

    Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.

    Code Info

    SYSTEM ID: 315470CPUWPV UDI #: 8406821038 00DE #: 2090255-001

    Distribution

    NY

    Quantity

    1