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U.S. Department of Health and Human Services

Class 3 Device Recall AliveECG App Version 2.1.2 used with AliveCor Heart Monitor

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 Class 3 Device Recall AliveECG App Version 2.1.2 used with AliveCor Heart Monitor see related information
Date Posted February 18, 2015
Recall Status1 Terminated on February 18, 2015
Recall Number Z-1125-2015
Recall Event ID 70363
510(K)Number K140933 
Product Classification Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
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).
Code Information v2.1.2
Recalling Firm/
Manufacturer
Alivecor SFO
30 Maiden Ln
Suite 600
San Francisco CA 94108-5429
For Additional Information Contact Albert Boniske
855-338-8800
Manufacturer 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.
FDA Determined
Cause 2
Software change control
Action AliveCor posted information on their website, Facebook Page and Twitter to alert users of the issue.
Quantity in Commerce 5600 active users with Alive ECG app for iOS .
Distribution Downloaded by Apple users - locations not shared by Apple.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DXH and Original Applicant = ALIVECOR, INC.
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