BEUDAMED
    FDA Recall Terminated

    ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.

    Recall: Z-1782-2010 · Initiated May 21, 2010

    Recall

    Recall Number
    Z-1782-2010
    Event Number
    55497
    Firm
    Defibtech LLC
    FEI Number
    3006403206
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 21, 2010
    Posted
    June 10, 2010
    Terminated
    September 29, 2020
    Address
    4 Progress Ave, Seymour, CT, 06483-3921

    Description

    ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.

    Reason

    The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy

    Action

    Defibtech, LLC issued an "Urgent Medical Device Safety Information and Correction" notification dated May 20, 2010 by email and hard copy via US Mail. The notification instructed Consignees on proper identification of affected product and steps to take for product replacement. For further information, contact your distributor or Defibtech Technical Support at [email protected] or call 1-877-453-4507 or 1-203-453-4507, 8:30 AM to 5:00 PM Monday - Friday, EST.

    Distribution

    Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.