BEUDAMED
    FDA Recall Terminated

    Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of various human physiological parameters.

    Recall: Z-1785-2010 · Initiated April 28, 2010

    Recall

    Recall Number
    Z-1785-2010
    Event Number
    55572
    Firm
    Mindray DS USA, Inc., dba Datascope Patient Monitoring
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 28, 2010
    Posted
    June 10, 2010
    Terminated
    June 22, 2011
    Address
    800 Macarthur Blvd, Mahwah, NJ, 07430

    Description

    Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of various human physiological parameters.

    Reason

    An issue with the Passport V Monitor has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational.

    Action

    Mindray issued Corrective action letters directly to all customers beginning April 28, 2010 by certified mail, return receipt requested. consignees were informed of the affected product. For further information, contact Mindray DS USA, Inc. at 1-201-995-8391.

    Distribution

    Worldwide Distribution -- United States (OH, TX, AZ, NY, MO, IL, FL and TN), Spain, Indonesia, Brazil, Italy, Columbia and British West Indies.

    Quantity

    24 US, 17 International