Recall Z-1125-2015 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
Alivecor SFO
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 o
| Date | Feb 18, 2015 (initiated Jan 9, 2015) |
| Status | Terminated |
| Reason | Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application. |
| Root cause | Software change control |
| Action | AliveCor posted information on their website, Facebook Page and Twitter to alert users of the issue. |
| Quantity | 5600 active users with Alive ECG app for iOS . |
| Distribution | Downloaded by Apple users - locations not shared by Apple. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140933 | ALIVECOR HEART MONITOR AliveCor, Inc., Aug 15, 2014 |