BEUDAMED
    FDA Recall 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 · Initiated January 9, 2015

    Recall

    Recall Number
    Z-1125-2015
    Event Number
    70363
    Firm
    Alivecor SFO
    FEI Number
    3009715978
    Product Code
    DXH
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    January 9, 2015
    Posted
    February 18, 2015
    Terminated
    February 18, 2015
    Address
    30 Maiden Ln, Suite 600, San Francisco, CA, 94108-5429

    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.

    Action

    AliveCor posted information on their website, Facebook Page and Twitter to alert users of the issue.

    Distribution

    Downloaded by Apple users - locations not shared by Apple.

    Quantity

    5600 active users with Alive ECG app for iOS .