BEUDAMED
    FDA Recall Terminated

    Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.

    Recall: Z-1813-2009 · Initiated April 22, 2009

    Recall

    Recall Number
    Z-1813-2009
    Event Number
    52439
    Firm
    Respironics California Inc
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 22, 2009
    Posted
    August 11, 2009
    Terminated
    July 13, 2012
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92011-1517

    Description

    Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.

    Reason

    The recall was initiated because through routine product monitoring Respironics discovered that under certain conditions, when operating on AC line power, a portion of the current from the External Battery charger is erroneously diverted to the ventilator. When this occurs, the External Battery charger may not transition correctly. Prolonged operation in this condition results in overcharging and

    Action

    Respironics California, Inc. issued an "Urgent - Medical Device Field Correction" notice dated April 22, 2009. Customers were informed of the affected device including corrective actions taken by the firm. A Respironics representative will contact customers to schedule service of the device. Further questions can be addressed by contacting Respironics US Customer Service at 1-800-345-6443.

    Distribution

    Worldwide Distribution: United States, Hong Kong, India, Mexico, South Africa and Vietnam.

    Quantity

    508