BEUDAMED
    FDA Recall Terminated

    Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier)

    Recall: Z-0581-2007 · Initiated February 17, 2007

    Recall

    Recall Number
    Z-0581-2007
    Event Number
    37394
    Firm
    Defibtech, LLC
    FEI Number
    3003521780
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 17, 2007
    Posted
    March 8, 2007
    Terminated
    June 9, 2021
    Address
    741 Boston Post Rd, Ste 201, Guilford, CT, 06437-2714

    Description

    Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier)

    Reason

    Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.

    Action

    Defibtech LLC initiated notification to customers/distributors on 2/17/07 by email. Hard copy letters followed on 2/22/07 with acknowledgement card. Users provided with instructions for 'Immediate Recommendations' until the unit''s software is upgraded. Distributors, their customers, and direct accounts instructed to locate affected units and upgrade these units in the field. Distributors, their customers, and direct accounts shall return to Defibtech documentation confirming unit software upgrade was completed..Press was issued by the firm on March 6, 2007

    Distribution

    Worldwide distribution ---- USA and countries of Canada, Uruguay, Jordon, Turkey United Kingdom, Saudi Arabia, Sweden France, South Africa, Cyprus, Spain, Germany India, Japan, Israel, Australia, Norway, Philppines Singapore, Poland, Germany, Italy, Switzerland Netherlands, Indonesia, United Arab Emirates Malaysia, Austria, Ireland, Kingdom of Bahrain, and Korea.

    Quantity

    14, 022