BEUDAMED
    FDA Recall 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 · Initiated November 16, 2012

    Recall

    Recall Number
    Z-2739-2016
    Event Number
    64761
    Firm
    Ge Healthcare It
    FEI Number
    3004526608
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 16, 2012
    Posted
    September 6, 2016
    Terminated
    January 11, 2017
    Address
    540 W Northwest Hwy, Barrington, IL, 60010-3051

    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.

    Action

    URGENT MEDICAL DEVICE CORRECTION letters dated November 16, 2012 and April 19, 2013, were sent to all affected customers.The letters requested that customers verify that all Enterprise Archive partitions have enough free space available and that the cache disk has at least 10% free space available. The letters further requested that customers whose disks are not being purged to the configured watermarks and the cache disk is almost full to contact their local GE service person. A permanent product correction (Service Pack 12 and release notes) will be provided by GE Healthcare IT. Customers with questions can contact their GE service representative or the GE Healthcare IT Remote Online Center Customer Care Center at 1-800-437-1171.

    Distribution

    Nationwide Distribution

    Quantity

    1,379 units