BEUDAMED
    FDA Enforcement Class II Terminated

    iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data

    Recall: Z-1697-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1697-2017
    Event ID
    76851
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 5, 2017
    Initiation Date
    April 4, 2016
    Classification Date
    March 29, 2017
    Termination Date
    April 10, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data

    Reason

    The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease.

    Code Info

    Versions 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.2, 8.40.2.1, 8.40.2.2, 8.70, 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, 9.0.0, 9.0.0.1, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.2.0, 9.3.0, 9.3.1, 9.4, 9.4.1, 9.4.2, 9.4.2.1, and 9.4.3.

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Canada, Belgium, Australia, Jordan, and the UK..

    Quantity

    298 sites potentially have the affected versions (290 of those in US)