BEUDAMED
    FDA Recall Terminated

    iConnect Access used with Merge 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-2531-2016 · Initiated January 30, 2016

    Recall

    Recall Number
    Z-2531-2016
    Event Number
    74734
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 30, 2016
    Terminated
    May 7, 2021
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    iConnect Access used with Merge 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.

    Action

    The recalling firm issued a letter dated 1/28/2016 via e-mail on 1/31/2016 or via certified mail if they did not have an e-mail address for the customer.

    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 potentially have the affected versions for both products