BEUDAMED
    FDA Recall Terminated

    Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.

    Recall: Z-0374-2019 · Initiated October 11, 2018

    Recall

    Recall Number
    Z-0374-2019
    Event Number
    81418
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 11, 2018
    Terminated
    March 20, 2023
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.

    Reason

    Synchronization failure

    Action

    On October 12, 2018 GE Healthcare send recall notification to all their consignees with the following instructions; If you do not use a Diagnostic viewer (e.g. Centricity Universal Viewer Zero Footprint Client or any 3rd party dicom viewer) connected directly to the same Centricity EA to display images for diagnostic purposes, your system is not affected by the safety issue. If you do use a Diagnostic viewer (e.g. Centricity Universal Viewer Zero Footprint Client or any 3rd party dicom viewer) connected directly to the same Centricity EA to display images for diagnostic purposes, please contact GE Healthcare service representative immediately. GE Healthcare will assist you in determining if your system is affected and, if necessary, will assist you with a solution to confirm that study updates are made in the Enterprise Archive, until GE Healthcare can install a correction on your system. GE Healthcare will provide a correction that will be installed by a GE service engineer. A GE Healthcare representative will contact you to arrange for the correction. This activity will be performed at no cost to you. Contact Information If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.

    Quantity

    13