BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1910-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1910-2019
    Event ID
    82998
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2019
    Initiation Date
    May 16, 2019
    Classification Date
    July 1, 2019
    Termination Date
    April 14, 2023
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

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

    Reason

    There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.

    Code Info

    UDI # 840682103800 Model # 2098249-002 Software Version: 6.0.9, 6.0SP9.01, CPACS 6.0 SP9.0.1, UV 6.0 SP9.0.1, UV 6.0 SP9.01.1, UV 6.0 SP9.0.1.2, UV 6.0 SP9.01.3, UV6.0 SP9.01.4, UV 6.0 SP9.01.5, UV 6.0 SP9.0.1.6, UV Version 6.0 SP5.0.4.1, UV Version 6.0 SP9, UV Version 6.0 SP9.0.0.1, UV Version 6.0 SP901, UV Version 6.0 SP9011, and UV Version 6.0 SP902

    Distribution

    Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom.

    Quantity

    145 (87 US 103 OUS)