FDA Safety Communication on Software Update for Cardioverter Defibrillator failure

In January 2018, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about a potential problem in the charging circuitry of the Zoll LifeVest 4000, which had the potential to prevent it from delivering a life-saving shock to patients. If the message “Call for Service – Message Code 102” is displayed on the screen, users have been advised to contact Zoll immediately for a replacement. A software update has been replaced that includes a more prominent warning to immediately contact Zoll should that message code appear. The full safety communication can be viewed at

https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm632783.htm?utm_campaign=LifeVest%204000%20Wearable%20Cardioverter%20Defibrillator%20by%20Zoll%3A%20Safety%20Communication&utm_medium=email&utm_source=Eloqua