BEUDAMED
    FDA Enforcement Class II Terminated

    Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.

    Recall: Z-0819-2020 · Reported January 29, 2020

    Enforcement

    Recall Number
    Z-0819-2020
    Event ID
    84584
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2020
    Initiation Date
    December 16, 2019
    Classification Date
    January 17, 2020
    Termination Date
    October 5, 2023
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.

    Reason

    Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.

    Code Info

    Model 2088026-9XX Versions 6.0 SP10 or higher

    Distribution

    Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.

    Quantity

    205