Safety Communications > UPDATE -- Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication

Safety Communications > UPDATE -- Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication

A new MedWatch Safety Alert was just added to the FDA Medical Device Safety web page.  TOPIC: LifeVest 4000 Wearable Cardioverter Defibrillator by Zoll: Safety Communication - Software Update AUDIENCE: Cardiology, Patient, Health Professional ISSUE: The FDA is reminding users of the Zoll LifeVest 4000 to contact the manufacturer immediately for a replacement device if their device displays the message: “Call for Service—Message Code 102.” FDA is also providing updated information on safety concerns related to the Zoll LifeVest 4000. Zoll is in the process of implementing a software update to all Zoll LifeVest devices to increase the prominence and persistence of the “Message Code 102” alert on the device’s display screen to help users identify and replace devices that may have an electrical issue which results in the device failing to deliver a shock to a patient if needed.

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