BEUDAMED
    FDA Recall Terminated

    The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX

    Recall: Z-0761-2017 · Initiated March 11, 2010

    Recall

    Recall Number
    Z-0761-2017
    Event Number
    75743
    Firm
    Physio-Control, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    March 11, 2010
    Terminated
    December 16, 2016
    Address
    11811 Willows Rd NE, Redmond, WA, 98052-2003

    Description

    The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX

    Reason

    Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010.

    Action

    Velocitor initiated this field action and notified affected customers on March 11, 2010. This action was reported to Physio-Control as completed on 12/21/2010.

    Distribution

    worldwide

    Quantity

    1399 units (866 in the US and 533 outside US)