BEUDAMED
    FDA Enforcement Class II Terminated

    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    Recall: Z-0353-2018 · Reported January 24, 2018

    Enforcement

    Recall Number
    Z-0353-2018
    Event ID
    78926
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zoll Manufacturing Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2018
    Initiation Date
    September 12, 2017
    Classification Date
    January 14, 2018
    Termination Date
    August 10, 2021
    Address
    121 Gamma Dr, N/A, Pittsburgh, PA, 15238-2919, United States

    Description

    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    Reason

    Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure

    Code Info

    All Serial Numbers

    Distribution

    US Nationwide

    Quantity

    33,670 units