FDA issues recall statement on insulin pump app after crash causes more than 200 injuries [USA TODAY]
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Source: USA TODAY
The U.S. Food and Drug Administration has issued a recall correction for an app that connects with an insulin pump due to a software issue that causes the app to crash, which can drain the battery of the insulin pump and has led to over 200 injuries. This is a Class 1 recall , which the FDA says is the most serious type of recall, and use of the device can lead to serious injury or death. The recall is for Version 2.7 of the t:connect mobile app, and Apple iOS-based software that works with the t:slim X2 insulin pump with Control-IQ technology. The app can also be used as a method of viewing pump information and limited control of the pump through compatible smartphone models, operating systems and pump software versions. The recalled version of the app was distributed between Feb. 12 and March 13, 2024. The FDA has recalled 85,863 devices in the U.S. According to the FDA, there is an issue with the app's software that can cause it to crash and be automatically relaunched by
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