Z-1125-2015Class III

Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used...

Name: Z-1125-2015 Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used...
Creator: Alivecor SFO
Published: 2015-01-09
License: https://open.fda.gov/license/

AliveCor / initiated 2015-01-09 / Terminated / root cause: software

FDA source

Alivecor SFO began a 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. The AliveCor Heart... on 2015-01-09. FDA classified it as Class III and gives the reason as "Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1125-2015
Classification: Class III
Status: Terminated
Initiated: 2015-01-09
Posted: 2015-02-18
Terminated: 2015-02-18
Recalling firm: AliveCor
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).
Product code: DXH Transmitters And Receivers, Electrocardiograph, Telephone
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.
Root cause tag: software
FDA root cause: Software change control
Action: AliveCor posted information on their website, Facebook Page and Twitter to alert users of the issue.
Quantity in commerce: 5600 active users with Alive ECG app for iOS .
Distribution: Downloaded by Apple users - locations not shared by Apple.
Product codes and lots: v2.1.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1125-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1125-2015	Class III	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-18

Product code DXH

K140933Class IIAlivecor Heart MonitorAliveCor, Inc. / cleared 2014-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)