Devices

Device Recall AliveECG App Version 2.1.2 used with AliveCor Heart Monitor

Model / Serial
v2.1.2
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Downloaded by Apple users - locations not shared by Apple.
Product Description
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).
Manufacturer
Alivecor SFO
1 Event
- Recall of Device Recall AliveECG App Version 2.1.2 used with AliveCor Heart Monitor

Manufacturer

Alivecor SFO

Manufacturer Address
Alivecor SFO, 30 Maiden Ln, Suite 600, San Francisco CA 94108-5429
Manufacturer Parent Company (2017)
AliveCor Inc.
Source
USFDA

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