BEUDAMED
    FDA Recall Terminated

    VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.

    Recall: Z-0638-2007 · Initiated January 31, 2007

    Recall

    Recall Number
    Z-0638-2007
    Event Number
    37318
    Firm
    Viasys Respiratory Care, Inc.dba Bird Products
    FEI Number
    2021710
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 31, 2007
    Posted
    March 20, 2007
    Terminated
    September 18, 2008
    Address
    1100 Bird Center Dr, Palm Springs, CA, 92262-8000

    Description

    VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.

    Reason

    The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.

    Action

    On January 31, 2007, 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 January 31, 2007, a product notification kit (including a product notification letter, download software, download instruction sheets and installation verification fax-back sheets) were mailed to all international customers via register mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package. Domestic Consignees will have product corrected by VIASYS service personnel. Self address postage paid envelopes will be provided with notifications to aid in effectiveness checks

    Distribution

    Worldwide Distribution ---USA and countries of Bangladesh, Bosnia, Brazil, China, Czech Republic, Ecuador, Estonia, Finland, France, Guatemala, Hong Kong, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Morocco, Netherlands, Portugal, Russian Federation, Taiwan, Thailand, Turkey & Vietnam.

    Quantity

    878