BEUDAMED
    FDA Enforcement Class II Terminated

    iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.

    Recall: Z-2532-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2532-2016
    Event ID
    74734
    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
    August 24, 2016
    Initiation Date
    January 30, 2016
    Classification Date
    August 12, 2016
    Termination Date
    May 7, 2021
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

    iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.

    Reason

    Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.

    Code Info

    iConnect Access V4.0 or earlier with any version of Ortho PACS and iConnect Access V4.1 with Ortho PACS V5.1.2 and earlier.

    Distribution

    Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.

    Quantity

    146 sites may have the affected version for both products