Alive ECG App 2 — Class III medical device recall Z-1125-2015
Terminated recall by Alivecor SFO, reported 2015-02-25. Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the appl
| Recall number | Z-1125-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alivecor SFO, San Francisco, CA, United States |
| Recall initiated | 2015-01-09 |
| Classified | 2015-02-18 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2015-02-18 |
| Quantity | 5,600 active |
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 for recall
Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1125-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.