BEUDAMED
    FDA Recall Terminated

    Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.

    Recall: Z-0457-2011 · Initiated July 2, 2010

    Recall

    Recall Number
    Z-0457-2011
    Event Number
    56147
    Firm
    Respironics California Inc
    FEI Number
    2518422
    Product Code
    MNT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 2, 2010
    Posted
    November 24, 2010
    Terminated
    December 1, 2010
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92011

    Description

    Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.

    Reason

    Respironics California Inc has received customer complaints of an odor or burning smell coming from the V60 Ventilator, and identified a component on the Power Management PCB that exhibited thermal damage.

    Action

    Phililps Healthcare issued an Urgent Medical Device Field Correction letter dated July 2, 2010 concerning the RespironicsV60 Ventilator issue. Customers will be contacted by US Field Service Technicians and international distributors to schedule and perform inspections and replacement of the affected component. The unit may continue to be used pending completion of the field inspection. Customers may contact Respironics US Customer Service about this action at 1 800 345 6443, option #5, then option #1.

    Distribution

    Worldwide Distribution: Throughout the US and Puerto Rico,, and to the countries of: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, India, Italy, Kenya, Kuwait, Libya, Malaysia, Oman, Netherlands, Norway, the United Kingdom, Saudi Arabia, and Spain.

    Quantity

    504