BEUDAMED
    FDA Enforcement Class II 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 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0761-2017
    Event ID
    75743
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Physio-Control, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    March 11, 2010
    Classification Date
    December 14, 2016
    Termination Date
    December 16, 2016
    Address
    11811 Willows Rd NE, Redmond, WA, 98052-2003, United States

    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.

    Code Info

    This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.

    Distribution

    worldwide

    Quantity

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