Heart monitor maker AliveCor recalled the AliveECG app version 2.1.2 for the Apple iOs operating system after learning the app crashes on use.
The Food and Drug Administration (FDA) recall notice says the recall affects about 5,600 active users on Apple’s iOS operating system. The app is used in conjunction with the AliveCor Heart Monitor, a device cleared by the FDA. 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), according to the FDA. Last month, AliveCor alerted users to the problem with posts on its website, and on Facebook and Twitter. The company pulled the app from distribution and quickly released an updated version (2.1.3) on iTunes. This version fixes the issues that cause a crash when updating from a previous version.
The FDA classified this action as a Class III recall. Recalls are categorized according to potential level of risk for the food, drug or device. In a Class III recall, “use of or exposure to a violative product is not likely to cause adverse health consequences.” The product generally violates FDA labeling or manufacturing laws, as is the case with the Alive ECG app.