FDA Medical Device Recalls (openFDA)
Alivecor SFO: 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).
- Recall number
- Z-1125-2015
- Recalling firm
- Alivecor SFO
- 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).
- Status
- Terminated
- Initiated
- 2015-01-09
- Posted
- 2015-02-18
- Terminated
- 2015-02-18
- Reason
- Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
- Root cause
- Software change control
- Action
- AliveCor posted information on their website, Facebook Page and Twitter to alert users of the issue.
- Quantity
- 5600 active users with Alive ECG app for iOS .
- Distribution
- Downloaded by Apple users - locations not shared by Apple.
- Lot, serial or model codes
- v2.1.2
- 510(k) numbers
- ["K140933"]
- PMA numbers
- not on file
- Product code
- DXH
- Firm FEI
- 3009715978
- Firm city
- San Francisco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28