BEUDAMED
    FDA Enforcement Class II Ongoing

    Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)

    Recall: Z-1690-2025 · Reported May 7, 2025

    Enforcement

    Recall Number
    Z-1690-2025
    Event ID
    96618
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Defibtech, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 7, 2025
    Initiation Date
    March 18, 2025
    Classification Date
    April 29, 2025
    Address
    741 Boston Post Rd Ste 201, Guilford, CT, 06437-2714, United States

    Description

    Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)

    Reason

    It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

    Code Info

    UDI-DIs: 00815098020034 (DDU-100, export version), 10815098020031 (DDU-100, export version (configuration level)). Lot numbers: 114008193, 114007350, 114007323, 114008190, 116012370, 116011831, 114006014, 114006766, 114006943, 114007067, 114007068, 114007071, 114007078, 114007091, 114007114, 114007123, 114007128, 114007137, 114007145, 114007478, 114007486, 114007517, 114007623, 114007696, 114007705, 114007770, 114007906, 114007907, 114007911, 114007914, 114007925, 114007933, 114007934, 114007964, 116011703, 116011708, 116011883, 116012476, 116012485, 116012488, 116012501, 104016266, 104016297,

    Distribution

    International Only: Switzerland.

    Quantity

    43 units (OUS only)