FDA Device recall Z-1125-2015
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
- FDA Device
- Class III
- terminated
- Published 2015-02-25
On 2015-02-25 the FDA classified a Class III recall of 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 by Alivecor Sfo, citing alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1125-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-01-09 |
| Published | 2015-02-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alivecor Sfo |
| Distribution | n/a |
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).
Reason
Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
Identifiers
| code_info | v2.1.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1125-2015%22
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