BEUDAMED
    FDA Enforcement Class II Terminated

    Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users service personnel and System administrators, and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-I profiles (published by IHE).

    Recall: Z-2739-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2739-2016
    Event ID
    64761
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ge Healthcare It
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2016
    Initiation Date
    November 16, 2012
    Classification Date
    September 6, 2016
    Termination Date
    January 11, 2017
    Address
    540 W Northwest Hwy, Barrington, IL, 60010-3051, United States

    Description

    Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users service personnel and System administrators, and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-I profiles (published by IHE).

    Reason

    There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.

    Code Info

    Version: 3.0.x

    Distribution

    Nationwide Distribution

    Quantity

    1,379 units