BEUDAMED
    FDA Enforcement Class II Terminated

    DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.

    Recall: Z-2393-2020 · Reported June 24, 2020

    Enforcement

    Recall Number
    Z-2393-2020
    Event ID
    85702
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Defibtech, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 24, 2020
    Initiation Date
    April 27, 2020
    Classification Date
    June 17, 2020
    Termination Date
    January 8, 2021
    Address
    741 Boston Post Rd, Suite 201, Guilford, CT, 06437-2714, United States

    Description

    DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.

    Reason

    A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.

    Code Info

    Serial Number 400101322

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.

    Quantity

    860