BEUDAMED
    FDA Enforcement Class II Terminated

    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.

    Recall: Z-2159-2016 · Reported July 20, 2016

    Enforcement

    Recall Number
    Z-2159-2016
    Event ID
    74510
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 20, 2016
    Initiation Date
    January 31, 2016
    Classification Date
    July 11, 2016
    Termination Date
    January 26, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.

    Reason

    Potential data loss occurs as a result of product archiving not working properly.

    Code Info

    Version 3.4

    Distribution

    Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution.

    Quantity

    49 sites have the affected software