Recall Underway for Power-Mad Defibrillator

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    ToolOfHis
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    Recall Underway for Power-Mad Defibrillator
    By Cole Petrochko, Staff Writer
    Published: April 25, 2010

    WASHINGTON — The FDA announced a class 1 recall — the agency’s most serious — of the LIFEPAK 15 heart monitor and defibrillator due to unexpected power issues.
    Affected devices can have the following problems after powering on:
    Turns itself off then back on
    Turns itself off and requires the operator to restart it
    Cannot be shut off

    Devices manufactured from March 26, 2009 to December 15, 2009 and shipped from March 27, 2009 to December 17, 2009 are included in the recall.
    The product’s manufacturer, Physio-Control Inc. of Redmond, Wash., mailed letters to customers who may have bought devices affected by the recall. It told customers not to discontinue device use, but to test the device reguarly according to the operating instructions. If testing revealed any of the abnormal power problems, users were to call the company’s technical support hotline.
    The notice added that service representatives would visit device sites within 60 days.
    Customers unsure if a device is included in the recall can check its serial number at the following Web site: http://www.physio-control-notices.com/LP15pcba” onclick=”window.open(this.href);return false;.
    Class 1 recalls are issued on devices that pose a reasonable risk of adverse health effects or death. Although the LIFEPAK’s power problems are potentially fatal, Physio-Control said it has not received any adverse event reports.

    http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/19739?utm_content=GroupCL&utm_medium=email&impressionId=1272269221113&utm_campaign=DailyHeadlines&utm_source=mSpoke&userid=247679″ onclick=”window.open(this.href);return false;

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