BEUDAMED
    FDA Recall Terminated

    Cardiac Science Powerheart Automated External Defibrillator G3 9300A

    Recall: Z-0916-2009 · Initiated October 13, 2008

    Recall

    Recall Number
    Z-0916-2009
    Event Number
    50064
    Firm
    Cardiac Science Corporation
    FEI Number
    2112020
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 13, 2008
    Posted
    February 25, 2009
    Terminated
    December 8, 2011
    Address
    3303 Monte Villa Pkwy, Bothell, WA, 98021-8969

    Description

    Cardiac Science Powerheart Automated External Defibrillator G3 9300A

    Reason

    Potential for AED to not deliver defibrillation therapy.

    Action

    On October 13, 2008 Cardiac Science began sending via Fed-Ex letters and software upgrade kits. Mailing of letters and software upgrade kits is anticipated to be completed by November 21, 2008. The letter instructs consignees to install the software update, assure that the AED information test file generated by the update software is returned to the firm, and complete the postage paid response card and return it to the firm. If the affected devices are no longer in the possession of the consignee, the consignee is to contact the firm and forward the update kit and letter to the person who has the AED in their possession. A separate letter is being sent to distributors. The letter advised to install the software upgrades for any units in stock or to forward the software upgrade along with the end user letter enclosed and that the AED information text file generated by the update software must be returned to the firm. The firm will visit the locations of individual national account customers and install the update. OEM partners will be notified and provided the information and update kits to provide to their customers.

    Distribution

    Worldwide Distribution: USA, Puerto Rico, Virgin Islands, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechoslovakia, Denmark, Dominican Republic, France, Germany, Greece, Guam, Hong Kong, Hungary, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Kuwait, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, UK, and Ukraine.

    Quantity

    9,633 devices