BEUDAMED
    FDA Enforcement Class II Terminated

    Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

    Recall: Z-0012-2022 · Reported October 13, 2021

    Enforcement

    Recall Number
    Z-0012-2022
    Event ID
    88595
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 13, 2021
    Initiation Date
    August 12, 2021
    Classification Date
    October 1, 2021
    Termination Date
    August 22, 2024
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

    Reason

    A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).

    Code Info

    Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794

    Distribution

    AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom

    Quantity

    49