BEUDAMED
    FDA Enforcement Class II Ongoing

    DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

    Recall: Z-1312-2023 · Reported April 5, 2023

    Enforcement

    Recall Number
    Z-1312-2023
    Event ID
    91799
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Defibtech, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 5, 2023
    Initiation Date
    February 14, 2023
    Classification Date
    March 30, 2023
    Address
    741 Boston Post Rd, Suite 201, Guilford, CT, 06437-2714, United States

    Description

    DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

    Reason

    A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.

    Code Info

    UDI-DI: 00815098020003 Serial Numbers: 101702198 101702263 101702424 101702524 101702535 101702540 101702544 101702545 101703267 101703269 101703272 101703274 101703276 101703277 101703278 101703281 101703312 101703326 101703378 101703407 101703411 101703412 101703419 101703424 101703427 101703464 101703465 101703600 101704106

    Distribution

    US Nationwide distribution.

    Quantity

    29 units