Alivecor SFO recalls Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the Aliv

Recalled February 25, 2015 · FDA recall Z-1125-2015 · Alivecor SFO

Hazard

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

Units

5600 active users with Alive ECG app for iOS .

Sold at

Downloaded by Apple users - locations not shared by Apple.

Description

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

Product

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).

Manufacturer(s)

Alivecor SFO

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →