BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2084-2013 · Initiated October 29, 2007

    Recall

    Recall Number
    Z-2084-2013
    Event Number
    48997
    Firm
    Respironics California Inc
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 29, 2007
    Posted
    August 26, 2013
    Terminated
    August 26, 2013
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92011-1517

    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.

    Action

    A Medical Device Field Correction letter dated 10/26/2007 was sent to all customers who received the Esprit Ventilator. The recall letter informed the customers of the problems identified and the actions to be taken. Customers with questions are instructed to contact Respironics' Customer Service Dept. at (800) 345-6443, select Option#5, then select Option #4.

    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)