FDA issues update on wearable cardioverter defibrillator

Editor's Note

The Food and Drug Administration (FDA) on July 25 issued an update for the Zoll LifeVest 4000 wearable cardioverter defibrillator.

The update provides information on efforts by Zoll to remedy the potential hazard of the device failing to deliver a life-saving shock if not replaced soon after displaying a “Call for Service−Message Code 102.”

Zoll issued a voluntary recall for the LifeVest 4000 in January and, since then, has updated the FDA with information on their plan to address the Message Code issue, including a WEAR Checklist and a software design change.