BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

    Recall: Z-2709-2016 · Reported September 7, 2016

    Enforcement

    Recall Number
    Z-2709-2016
    Event ID
    75027
    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
    September 7, 2016
    Initiation Date
    February 9, 2016
    Classification Date
    September 1, 2016
    Termination Date
    August 24, 2017
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

    Reason

    A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).

    Code Info

    Versions 10.1 and 10.1.1

    Distribution

    Nationwide Distribution

    Quantity

    116 customers potentially have the affected versions