BEUDAMED
    FDA Enforcement Class II Terminated

    Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000

    Recall: Z-2084-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2084-2013
    Event ID
    48997
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Respironics California Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    October 29, 2007
    Classification Date
    August 26, 2013
    Termination Date
    August 26, 2013
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92011-1517, United States

    Description

    Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000

    Reason

    The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable.

    Code Info

    Model Number: V1000

    Distribution

    USA Nationwide and Worldwide to Algeria, Argentina, Australia, Bangladesh, Brazil, Cambodia, Canada, Chile, Colombia, Ecuador, Egypt, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Libya, Malaysia, Mexico, Pakistan, Peru, Philippines, Puerto Rico, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.

    Quantity

    3,255 units (2302 units in US)