Reported Feb 25, 2015 · Terminated
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the…
Alivecor SFO
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alivecor SFO · 30 Maiden Ln · San Francisco, CA · 94108-5429
Is this the product you have?
- 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).
- Lot codes and dates
- v2.1.2
- Amount recalled
- 5600 active users with Alive ECG app for iOS .
Why it was recalled
Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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