BEUDAMED
    FDA Recall Open, Classified

    Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language)

    Recall: Z-1694-2025 · Initiated March 18, 2025

    Recall

    Recall Number
    Z-1694-2025
    Event Number
    96653
    Firm
    Defibtech, LLC
    FEI Number
    3003521780
    Product Code
    MKJ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 18, 2025
    Posted
    April 29, 2025
    Address
    741 Boston Post Rd, Ste 201, Guilford, CT, 06437-2714

    Description

    Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual 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).

    Action

    On March 18, 2025 URGENT FIELD SAFETY NOTICE letters were sent to customers. Actions to be taken by the Customer/User: 1. Confirm receipt of this notice by replying to this email with RECEIVED 2. Locate and verify the SN affected by this Field Notice listed below. The serial number is located at the back of the Lifeline View Fully Automatic Defibrillator. 3. Please complete the attached Customer Reply Form and email the form to FA2025- [email protected]. 4. Once the Customer Reply Form is received, Defibtech will contact you to arrange disposition based on your selection. Your device will be refunded or replaced at no cost to you. If you have questions now, please feel free to contact us using the email address: [email protected]. Defibtech is committed to ensuring our products meet the highest quality standards and that our customers are fully supported. I sincerely apologize for any inconvenience this may cause you. As always, Defibtech Customer Support is available by calling 1-877-453-4507, 7:30 A.M. to 6:00 P.M. (Eastern Standard Time), Monday - Friday. Thank you for your attention and cooperation.

    Distribution

    OUS only: Switzerland.

    Quantity

    13 units (OUS only)