BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

    Recall: Z-1415-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1415-2017
    Event ID
    76401
    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
    March 29, 2017
    Initiation Date
    April 4, 2016
    Classification Date
    March 20, 2017
    Termination Date
    March 20, 2017
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

    Reason

    A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.

    Code Info

    Version 9.0.9 and earlier using EchoIMS.

    Distribution

    US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.

    Quantity

    17 sites potentially have the affected versions