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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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