BEUDAMED
    FDA Recall Open, Classified

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a) 2089507-120; b) 2089507-129; c) 2089507-131; d) 2089507-135; e) 2089507-136; f) 2089507-140; g) 2089507-144; h) 2089507-145; i) 2089507-149; j) 2089507-153; k) 2089507-154; l) 2089507-155; m) 2089507-156; n) 2089507-157; o) K2037DAED; p) K2037DBED; q) K2037DED; r) K2037DJED; s) K2037DNED; t) K2042TTED; u) K2049DC; v) K2049DD; w) K2049DF; x) P2037DAED; y) P2037DBED; z) P2037DED; aa) To be provided

    Recall: Z-0039-2025 · Initiated August 29, 2024

    Recall

    Recall Number
    Z-0039-2025
    Event Number
    95307
    Firm
    GE Healthcare
    FEI Number
    3004526608
    Product Code
    LLZ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 29, 2024
    Posted
    October 9, 2024
    Address
    500 W Monroe St, Chicago, IL, 60661-3671

    Description

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a) 2089507-120; b) 2089507-129; c) 2089507-131; d) 2089507-135; e) 2089507-136; f) 2089507-140; g) 2089507-144; h) 2089507-145; i) 2089507-149; j) 2089507-153; k) 2089507-154; l) 2089507-155; m) 2089507-156; n) 2089507-157; o) K2037DAED; p) K2037DBED; q) K2037DED; r) K2037DJED; s) K2037DNED; t) K2042TTED; u) K2049DC; v) K2049DD; w) K2049DF; x) P2037DAED; y) P2037DBED; z) P2037DED; aa) To be provided

    Reason

    GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series.

    Action

    GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 08/29/2024 via mail. The notice explained the issue with the device, safety issue, and provided the following: "Actions to be taken by Customer/User: You can continue to use your device by following the recommendation below. To find the latest report, review all the reports available for the study in the Series Selector. Navigation to the series selection can be found in the User Manual under Section 2.4.3 of The Series Selector, with the subheading of Open a report/document. Please ensure all potential users in your facility are made aware of this safety notification and the recommended action." GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide distribution.

    Quantity

    1500 units