BEUDAMED
    FDA Recall Terminated

    Esprit Ventilator

    Recall: Z-1230-04 · Initiated February 20, 2002

    Recall

    Recall Number
    Z-1230-04
    Event Number
    29385
    Firm
    Respironics California Inc
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 20, 2002
    Posted
    July 28, 2004
    Terminated
    December 2, 2004
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92009-1517

    Description

    Esprit Ventilator

    Reason

    Flow sensors would exhibit drift.

    Action

    Oxygen flow sensors were replaced in all ventilators by service technicians in the USA. Parts were given to foreign consignees. Recall is complete.

    Distribution

    Nationwide, Australia, Argentina, Brazil, Canada, Chile, Colombia, Spain, Germany, Hong Kong, India, Italy, Japan, Korea, Mexico, Malaysia, Panama, Philipines, Pakistan, Puerto Rico, Singapore, Thailand, Turkey, Taiwan, Venezuela Vietnam

    Quantity

    907