BEUDAMED
    FDA Recall 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 · Initiated April 13, 2016

    Recall

    Recall Number
    Z-2123-2017
    Event Number
    77124
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 13, 2016
    Posted
    May 22, 2017
    Terminated
    July 17, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    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.

    Action

    The recalling firm issued a "Medical Device Correction" letter dated 4/13/2016 via e-mail. The letter identified the affected product, issue involved, potential harm, a work around, as well as the actions to be performed by both the customer and firm. Merge Technical Support will contact customers to discuss the fix. Customers are to ensure that all users are provided the notice. If the affected product was further distributed, those customers should be identified and notified of the issue. A copy of the notice may be provided to those customers. If there are additional questions, customers can e-mail [email protected].

    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