BEUDAMED
    FDA Recall Terminated

    NICO Model 7300 Cardiopulmonary Management System

    Recall: Z-1535-06 · Initiated August 11, 2006

    Recall

    Recall Number
    Z-1535-06
    Event Number
    36081
    Firm
    Respironics Novametrix, LLC.
    FEI Number
    1219324
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 11, 2006
    Posted
    September 29, 2006
    Terminated
    June 12, 2012
    Address
    5 Technology Dr, Wallingford, CT, 06492-1942

    Description

    NICO Model 7300 Cardiopulmonary Management System

    Reason

    Audible alarm may not sound during an alert condition

    Action

    Respironics notified consignees of the problem with the audible alarm by certified letter on 8/28/06. The correction requires replacement of a speaker upgrade kit.

    Distribution

    Worldwide distribution --- USA and countries of United Arab Emirates, Argentina, Austria, Australia, Belgium, Bulgaria, Bahrain, Brazil, Canada, Canton of Aargau Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Algeria, Ecuador, Egypt, Spain, Finland, France, Great Britain, Guam, Hong Kong, Hungary, Ireland, India, Italy, Jamaica, Jordon, Japan, Korea, Kuwait, Lebanon, Lithuania, Morocco, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Peru, Phillippines, Puerto Rico, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovania, Slovakia, Thailand, Turkey, Taiwan, Uruguay, Venezuala, and South Africa.

    Quantity

    2,432 units