BEUDAMED
    FDA Recall Terminated

    LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.

    Recall: Z-0294-04 · Initiated November 12, 2003

    Recall

    Recall Number
    Z-0294-04
    Event Number
    27864
    Firm
    Medtronic Physio Control Corp
    FEI Number
    3015876
    Product Code
    MKI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 12, 2003
    Posted
    January 6, 2004
    Terminated
    February 25, 2004
    Address
    11811 Willows Rd NE, Redmond, WA, 98073

    Description

    LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.

    Reason

    Device unable to recognize the connection to the hard paddles accessory.

    Action

    Beginning on 11/12/03 representatives from the firm visited the consignees and replaced the paddles. A letter dated November 2003 was provided to the consignees.

    Distribution

    The firm distributed devices to 32 hospitals and medical centers located throughout the United States.

    Quantity

    180 sets