BEUDAMED
    FDA Recall Terminated

    Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.

    Recall: Z-0623-06 · Initiated January 27, 2006

    Recall

    Recall Number
    Z-0623-06
    Event Number
    34685
    Firm
    Cardiac Science Corporation
    FEI Number
    2112020
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 27, 2006
    Posted
    March 2, 2006
    Terminated
    June 25, 2006
    Address
    3303 Monte Villa Pkwy, Bothell, WA, 98021

    Description

    Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.

    Reason

    Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge.

    Action

    Affected consignees were notified via telephone. If no phone contact could be made, a Urgent: Medical Device Recall letter dated 02/02/06 was sent with return receipt requested. Customers were asked to locate affected devices and remove them from service. A new AED would be sent to the customers and the customers are asked to return the affected device.

    Distribution

    58 customers within the US: AZ, CA, CO, DC,FL, GA, Nationwide, Hungary and Singapore. IL, IN, KS, KY, LA, MI, MO, NC, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI. 2 customers OUS to include: Hungary and Singapore.

    Quantity

    91