BEUDAMED
    FDA Enforcement Class II Ongoing

    Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.

    Recall: Z-0721-2023 · Reported December 28, 2022

    Enforcement

    Recall Number
    Z-0721-2023
    Event ID
    91159
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2022
    Initiation Date
    October 28, 2022
    Classification Date
    December 16, 2022
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.

    Reason

    There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.

    Code Info

    Installed Product ID: YP3150-Centricity Universal Viewer-01639018

    Distribution

    Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.

    Quantity

    1 unit