BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Cardio software. 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-0729-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0729-2017
    Event ID
    75825
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    December 21, 2016
    Initiation Date
    March 28, 2016
    Classification Date
    December 9, 2016
    Termination Date
    March 20, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge Cardio software. 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

    If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient).

    Code Info

    Versions: 8.30.0, 8.30.1, 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, and 10.1.1

    Distribution

    Nationwide Distribution

    Quantity

    198 sites potentially have the effected versions