BEUDAMED
    FDA Recall Terminated

    VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version)

    Recall: Z-0986-2008 · Initiated December 17, 2007

    Recall

    Recall Number
    Z-0986-2008
    Event Number
    46215
    Firm
    Viasys Respiratory Care, Inc.dba Bird Products
    FEI Number
    2021710
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 17, 2007
    Posted
    May 14, 2008
    Terminated
    May 13, 2008
    Address
    1100 Bird Center Dr, Palm Springs, CA, 92262-8000

    Description

    VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version)

    Reason

    Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.

    Action

    On December 18, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (registed mail) and a product notification letter was mailed to all international customers via Federal Express. The recall letter informed the customers of the problem and also inform them that a Cardinal Health (Viasys) service representative will be contacting them immediately to arrange & service their ventilator. For futher information please contack Andrea von Muller at 760-778-7323.

    Distribution

    Worldwide Distribution --- USA including states of AL, CA, MA, NM, NV, and NY and country of Italy.

    Quantity

    28