BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.

    Recall: Z-2123-2017 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2123-2017
    Event ID
    77124
    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
    May 31, 2017
    Initiation Date
    April 13, 2016
    Classification Date
    May 22, 2017
    Termination Date
    July 17, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.

    Reason

    Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.

    Code Info

    Versions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.

    Distribution

    Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.

    Quantity

    30 sites have the potentially affected software versions