BEUDAMED
    FDA Recall Terminated

    iConnect Enterprise Archive software.

    Recall: Z-1700-2017 · Initiated April 4, 2016

    Recall

    Recall Number
    Z-1700-2017
    Event Number
    76768
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 4, 2016
    Terminated
    October 5, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    iConnect Enterprise Archive software.

    Reason

    The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease.

    Action

    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

    Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government and military distribution was also made.

    Quantity

    371 sites potentially have the affected software