BEUDAMED
    FDA Enforcement Class II Ongoing

    GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.

    Recall: Z-1333-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1333-2022
    Event ID
    90454
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2022
    Initiation Date
    June 8, 2022
    Classification Date
    July 5, 2022
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.

    Reason

    Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)

    Code Info

    UDI 00840682102988, Versions 6.0 SP6 through SP11.4

    Distribution

    Worldwide distribution.

    Quantity

    1,934 units