Z-1125-2015 Class III Terminated
FDA device recall Z-1125-2015 was initiated by Alivecor SFO on January 9, 2015 and is designated Class III. 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. The recall status is terminated (terminated February 18, 2015). Affected quantity: 5600 active users with Alive ECG app for iOS ..
Recall Details
- Product Type
- Devices
- Report Date
- February 25, 2015
- Initiation Date
- January 9, 2015
- Termination Date
- February 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5600 active users with Alive ECG app for iOS .
Product Description
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).
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.
Distribution Pattern
Downloaded by Apple users - locations not shared by Apple.
Code Information
v2.1.2