Device 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).
Z-1125-2015
Product summary
- Firm
- Alivecor SFO
- Event
- Event 70363
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5600 active users with Alive ECG app for iOS .
- Official record key
device-enforcement:Z-1125-2015
Official wording
Reason: Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
Code information: v2.1.2
Distribution pattern: Downloaded by Apple users - locations not shared by Apple.
Derived failure modes
-
Unknown
Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.