AliveCor has recalled their Alive ECG app version 2.1.2 due to the app crashing upon use affecting 5600 active users on iOS, according to a FDA recall notice. Utilized in conjunction with the FDA cleared AliveCor Heart Monitor, the AliveECG app records accurate electrocardiogram (ECGs) and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
AliveCor has posted information on its website, Facebook Page and Twitter to alert users about the issue. The FDA identified it as a Class III recall which is described as a situation in which “use of or exposure to a violative product is not likely to cause adverse health consequences.”
AliveCor quickly released an updated version 2.1.3 on iTunes, which fixes issues causing crash when updating from previous version. The recall status is still open on the FDA website.
2/24 Update: Recall status has been changed to “closed”