BEUDAMED
    FDA Recall Terminated

    RESPIRONICS V60 VENTILATOR

    Recall: Z-0176-2010 · Initiated October 26, 2009

    Recall

    Recall Number
    Z-0176-2010
    Event Number
    53676
    Firm
    Respironics California Inc
    FEI Number
    2518422
    Product Code
    MNT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 26, 2009
    Posted
    November 11, 2009
    Terminated
    October 13, 2011
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92011-1517

    Description

    RESPIRONICS V60 VENTILATOR

    Reason

    The recall was initiated to correct an issue with a component on the V60 Ventilator Power Management (PM) Printed Circuit Board (PCB). A component on the PCB has the potential to break off or become damaged if the PCB is removed from the ventilator. If this occurs, the ventilator may not properly switch between back up battery power and AC power. This can result in power loss during ventilation fo

    Action

    The recall notification was initiated October 26, 2009 with the firm mailing a Urgent Medical Device Field Correction letter to the affected customers. The letter informed the customers of the reason for the notice and how Respironics Field Service Technicians were going to correct this issue. The letter also gave the customers instructions to follow pending the completion of the field inspection/replacement. For questions or additional information contact Respironics US Customer Service at 1.800.345.6443, Option #5 then Option #1.

    Distribution

    Nationwide and Internationally to : Libya, Hong Kong, France, Italy, India, Spain, United Kingdom, Germany, Netherlands and Saudi Arabia

    Quantity

    524