BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    Recall: Z-1517-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1517-2017
    Event ID
    76719
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2017
    Initiation Date
    September 22, 2015
    Classification Date
    March 21, 2017
    Termination Date
    August 8, 2019
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    Reason

    Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.

    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, and 9.0.8

    Distribution

    US Nationwide Distribution.

    Quantity

    89 sites potentially have the affected software