BEUDAMED
    FDA Enforcement Class III Terminated

    Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

    Recall: Z-1125-2015 · Reported February 25, 2015

    Enforcement

    Recall Number
    Z-1125-2015
    Event ID
    70363
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alivecor SFO
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    February 25, 2015
    Initiation Date
    January 9, 2015
    Classification Date
    February 18, 2015
    Termination Date
    February 18, 2015
    Address
    30 Maiden Ln, Suite 600, San Francisco, CA, 94108-5429, United States

    Description

    Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

    Reason

    Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.

    Code Info

    v2.1.2

    Distribution

    Downloaded by Apple users - locations not shared by Apple.

    Quantity

    5600 active users with Alive ECG app for iOS .