BEUDAMED
    FDA Recall Terminated

    Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics

    Recall: Z-0903-04 · Initiated June 1, 2001

    Recall

    Recall Number
    Z-0903-04
    Event Number
    28803
    Firm
    Respironics California Inc
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 1, 2001
    Posted
    July 20, 2004
    Terminated
    May 12, 2004
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92009-1517

    Description

    Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics

    Reason

    Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.

    Action

    Firm technicians and foreign representatives were responsible for updating software on or about 6/1/01.

    Distribution

    Nationwide, Argentina, Brazil, Canada, China, Chile, Egypt, India, Italy, Japan, Korea, Mexico, Pakistan, Panama, Philipines, Puerto Rico, Singapore, Spain, Thailand, Turkey, Vietnam.

    Quantity

    749