Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the Aliv
FDA device recall Z-1125-2015 · posted 2015-02-18 · Terminated
Recall details
- Recalling firm
- Alivecor SFO
- 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.
- Action taken
- AliveCor posted information on their website, Facebook Page and Twitter to alert users of the issue.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- DXH
- Quantity affected
- 5600 active users with Alive ECG app for iOS .
- Distribution
- Downloaded by Apple users - locations not shared by Apple.
- Date initiated
- 2015-01-09
- Date posted
- 2015-02-18
- Date terminated
- 2015-02-18
- Location
- San Francisco, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALIVECOR HEART MONITOR (K140933) | AliveCor, Inc. | 2014-08-15 |