BEUDAMED
    FDA Recall Terminated

    Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibrillation with Medtronic QUICK-COMBO Electrodes.

    Recall: Z-1714-2008 · Initiated January 23, 2008

    Recall

    Recall Number
    Z-1714-2008
    Event Number
    47224
    Firm
    Cardiac Science Corporation
    FEI Number
    2112020
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 23, 2008
    Posted
    September 17, 2008
    Terminated
    December 8, 2011
    Address
    3303 Monte Villa Pkwy, Bothell, WA, 98021-8969

    Description

    Electrode Adaptor Cable Quick-Combo System, Model 9055 The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibrillation with Medtronic QUICK-COMBO Electrodes.

    Reason

    Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.

    Action

    On 1/23/08 the firm issued a letter titled "9055 Electrode Adaptor IFU Update" to consignees sent via certified return receipt requested. Enclosed with the letter is an updated Instructions For Use, part number 70-00180-01, revision C. Consignees were advised to discard their old Instructions For Use. For assistance, contact Cardiac Science at 1-888-466-8686.

    Distribution

    Distributed Nationwide US and Canada and Internationally to: Norway and Guam

    Quantity

    63