BEUDAMED
    FDA Recall 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 · Initiated April 4, 2016

    Recall

    Recall Number
    Z-1697-2017
    Event Number
    76851
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 4, 2016
    Terminated
    April 10, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    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.

    Action

    MERGE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers. The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A second letter dated 7/11/2016 was issued to nonresponders.

    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)