BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

    Recall: Z-0793-2019 · Reported February 13, 2019

    Enforcement

    Recall Number
    Z-0793-2019
    Event ID
    81975
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2019
    Initiation Date
    December 20, 2018
    Classification Date
    February 1, 2019
    Termination Date
    April 9, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

    Reason

    When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis.

    Code Info

    Centricity Universal Viewer versions 6.0 SP4 or higher with Breast Imaging integrated with either IDI Mammo Workstation version 4.7.x or any version of SenoIris.

    Distribution

    Worldwide Distribution: US (nationwide) in states of: AZ, CA, CO, DE, FL, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, MT, NE, NJ, NV, NY, OH, PA, PR, SC, SD, TN, TX, VA, VT, and WI; and countries of: Antigua, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Cote d'Ivoire, France, Germany, Guatemala, India, Italy, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Panama, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

    Quantity

    297 (131 US; 166 OUS)