BEUDAMED
    FDA Enforcement Class I Terminated

    The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.

    Recall: Z-1257-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1257-2017
    Event ID
    76252
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Physio-Control, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 15, 2017
    Initiation Date
    January 13, 2017
    Classification Date
    March 3, 2017
    Termination Date
    August 22, 2019
    Address
    11811 Willows Rd NE, N/A, Redmond, WA, 98052-2003, United States

    Description

    The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.

    Reason

    The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.

    Code Info

    Affected Product Part Numbers: 320371500XX. There are 133,330 affected serial numbers.

    Distribution

    Worldwide Distribution - US (nationwide) and in the following countries: Bahrain, Belize, Cambodia, Chile, China, C¿te d'Ivoire, Ecuador, Germany, Honduras, Hong Kong, India, Indonesia, Jamaica, Myanmar, Netherlands, Niger, Philippines, Saudi Arabia, Senegal, Singapore, Sri Lanka, Thailand, Tunisia, Ukraine, and Zambia.

    Quantity

    total 133,330 units (50,046 units in the US)