Cl II Alive ECG App 2.1.2

Company:Alivecor SFO.
Date of Enforcement Report: 3/4/2015
Class lI:

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).
Recall Number Z-1125-2015

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

RECALLING FIRM/MANUFACTURER
Alivecor SFO, San Francisco, CA on 1/9/2015 Voluntary: Firm Initiated recall has been terminated

VOLUME OF PRODUCT IN COMMERCE
5600 active users with Alive ECG app for iOS .

DISTRIBUTION
Downloaded by Apple users – locations not shared by Apple.

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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