Medtronic, which develops, manufactures and sells medical therapy devices, has issued a voluntary recall of its MiniMed 600 series or 700 series insulin pumps due to the pump's potentially shortened battery life.
The company issued a field action, starting on July 31, notifying customers globally that they should monitor their MiniMed pump's built-in alarms and alerts to keep track of battery...
The FDA has issued a class two device recall for Senseonics’ Eversense continuous glucose monitoring system. This posting follows a September notice from the company that alerted providers and distributors in the US that the sensors of certain devices may stop working prematurely.
Senseonics identified a small number of Eversense Sensors that have prematurely stopped functioning due to inadequate...
The stakes are high when it comes to medical device safety, but recall notifications aren’t always easy to find.
With this in mind, a new Boston-based startup called Soom is aiming to target this issue with its new app, called SoomSafety. The app lets users scan the bar code of a medical device to bring up all safety and recall information about the product.
Soom pulls from the FDA’s open-source...
AliveCor recalled Version 2.1.2 of its AliveECG iOS app under an FDA Class III recall according to an FDA posting that went up this month. But in actuality, the "recall," which happened in mid-January, was little more than a run-of-the-mill buggy app update, which the company patched within two days.
"If you read the definitions of recall, if you, as a manufacturer of medical devices, place a...
