Physio-Control
This article was originally published in The Gray Sheet
Executive Summary
Conducting field correction recall of all LifePak 10 external defibrillator/monitors because of device problems including premature wear of the product's coil cords. In some high- usage situations, the cords have worn out in two-to-three years instead of the expected five. The first replacements will take place on older devices. Currently manufactured devices continue to be shipped with the older coils due to insufficient quantities of new coils. The recall follows the May reintroduction of the LifePak 10, the only device Physio-Control has resumed marketing since it shut down operations a year ago because of regulatory problems ("The Gray Sheet" May 24, I&W-4). Physio-Control says it anticipated the LifePak 10 recall when it resumed marketing and that FDA was aware of the situation.