Home / Recalls / Alivecor SFO / Z-1125-2015

Z-1125-2015 Class III Terminated

Recalled by Alivecor SFO — San Francisco, CA

Recall Details

Product Type
Devices
Report Date
February 25, 2015
Initiation Date
January 9, 2015
Termination Date
February 18, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5600 active users with Alive ECG app for iOS .

Product 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 for Recall

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

Distribution Pattern

Downloaded by Apple users - locations not shared by Apple.

Code Information

v2.1.2