BEUDAMED
    FDA Recall Terminated

    DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020225, 00815098020232 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-2392-2020 · Initiated April 27, 2020

    Recall

    Recall Number
    Z-2392-2020
    Event Number
    85702
    Firm
    Defibtech, LLC
    FEI Number
    3003521780
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 27, 2020
    Terminated
    January 8, 2021
    Address
    741 Boston Post Rd, Suite 201, Guilford, CT, 06437-2714

    Description

    DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020225, 00815098020232 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.

    Action

    The firm contacted affected customers via email and mailed letter on April 27, 2020. Distributors were asked to forward letters to end users. Customers were informed that affected products may abort a shock delivery or reset unexpectedly. Customers were asked to return all affected products for screening. Actions to be taken by the Customer/User: 1. If you have additional AEDs on hand , please quarantine and return any affected units as identified in the Attachment for screening or replacement. Do not include the pads and battery packs when you return your unit. 2. If no other AEDs are available, please continue using the device with caution until a loaner or replacement is provided. 3. Ensure that all users of the AED are informed of the product issue. Defibtech will provide support for handling all aspects of the return of identified units for screening. The firm will contact customers to help them with the process. If you have questions now, please contact the firm using the email address [email protected]. Additionally, Defibtech Customer Support is available by calling 1-877-453-4507, 8:30 A.M. to 5:30 P.M. (Eastern), Monday - Friday.

    Distribution

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

    Quantity

    860