BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Cardio software.

    Recall: Z-1486-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1486-2017
    Event ID
    76431
    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 19, 2017
    Termination Date
    July 26, 2019
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge Cardio software.

    Reason

    Cardio study list does not show STAT studies without refreshing.

    Code Info

    Versions 9.0; 9.0.1; 9.0.2; 9.0.3; 9.0.4; 9.0.5; 9.0.6; 9.0.7, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, 10.1.1, and 10.1.2.

    Distribution

    Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/government distribution.

    Quantity

    217 sites potentially have the affected versions