BEUDAMED
    FDA Recall Terminated

    Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653

    Recall: Z-0480-2007 · Initiated October 20, 2006

    Recall

    Recall Number
    Z-0480-2007
    Event Number
    36740
    Firm
    Viasys Respiratory Care, Inc.
    FEI Number
    2021710
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 20, 2006
    Posted
    January 11, 2007
    Terminated
    September 3, 2008
    Address
    1100 Bird Center Dr, Palm Springs, CA, 92262-8000

    Description

    Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653

    Reason

    The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.

    Action

    On November 2, 2006, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Consignees are informed in the notification letter that service calls are in process of being scheduled to update domestic consignees. On November 4, 2006, a product notification letter was mailed to all international customers via registed mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package.

    Distribution

    Worldwide including USA, Canada, Estonia, Belgium, Saudi Arabia, Brazil, Thailand, United Arab Emirates, Syria, Portugal, Jordan, Italy, Latvia, Hong Kong China, Ecuador, Jamaica, Dominican Republic, New Zealand, Australia, Czech Republic, Bolivia, Austria, Greece, United Kingdom (England), Turkey, Chile, Japan, India, Mexico, Uruguay, Algeria, Vietnam, Costa Rica, Ireland, Switzerland, Bahamas, Singapore, South Africa, Philippines, Spain, France, Peru, Lebanon, Taipei, Malaysia, Netherlands, South Korea, Israel & Slovak Republic

    Quantity

    1478