Date Initiated by Firm |
January 09, 2015 |
Date Posted |
February 18, 2015 |
Recall Status1 |
Terminated 3 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DXH and Original Applicant = ALIVECOR, INC.
|