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Terminated

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).

FDA Recall Z-1125-2015 · Posted 2015-02-18

Recalling FirmAlivecor SFO
Recall StatusTerminated
Product CodeDXH
Date Initiated2015-01-09
Date Terminated2015-02-18
Product Quantity5600 active users with Alive ECG app for iOS .

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.

Firm Action

AliveCor posted information on their website, Facebook Page and Twitter to alert users of the issue.

Root Cause

Software change control

Distribution Pattern

Downloaded by Apple users - locations not shared by Apple.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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