Alive ECG App 2 recalled over injury risk

Recall date

January 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 Ali…

Recall number

Z-1125-2015

FDA classification

Class III

Brand / firm

Alivecor SFO

Sold / distributed

Downloaded by Apple users - locations not shared by Apple.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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).