BEUDAMED
    FDA Recall Terminated

    Biphasic LIFEPAK 12 defibrillator / monitor.

    Recall: Z-0811-2010 · Initiated March 31, 2009

    Recall

    Recall Number
    Z-0811-2010
    Event Number
    54005
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 31, 2009
    Posted
    February 22, 2010
    Terminated
    August 8, 2013
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    Biphasic LIFEPAK 12 defibrillator / monitor.

    Reason

    Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. Delay or prevention of defibrillation therapy may contribute to the death of a viable patient.

    Action

    Consignees were sent a notification letter dated March 2009 that explained firm representatives would follow up with each customer within 30 days to arrange an update to affected devices. Affected Biphasic PCBAs will be replaced. Customers advised to keep the devices in use and to continue to perform daily User Test.

    Distribution

    Distributed domestically and internationally to hospitals, clinics, etc. Foreign distribution to the following countries: Australia, Brazil, Canada, Colombia, Costa Rica, Germany, Hong Kong, Mexico, Netherlands, and Puerto Rico.

    Quantity

    1718