BEUDAMED
    FDA Recall Terminated

    V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis Arrhythmia Detection Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) Cardiac Output (CO) Respiratory Gasses Respiration Rate Temperature The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices

    Recall: Z-1102-2012 · Initiated October 14, 2011

    Recall

    Recall Number
    Z-1102-2012
    Event Number
    60976
    Firm
    Mindray DS USA, Inc. d.b.a. Mindray North America
    FEI Number
    2221819
    Product Code
    DRT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 14, 2011
    Posted
    February 24, 2012
    Terminated
    June 11, 2013
    Address
    800 MacArthur Blvd., Mahwah, NJ, 07430

    Description

    V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis Arrhythmia Detection Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) Cardiac Output (CO) Respiratory Gasses Respiration Rate Temperature The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices

    Reason

    A system database corruption may occur that causes the V Series Monitor to reset.

    Action

    The firm, Mindray, sent an "URGENT PRODUCT CORRECTIVE ACTION" letter dated October 14, 2011 on October 17, 2011 via certified mail, return receipt requested, signature required to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact their Mindray Service Representative at 1-800-288-2121, to arrange for software upgrade of the V Series Monitor(s) in their facility. If you have any questions, contact Manager, Regulatory Affairs and Clinical Affairs at 201-995-8407 or email: [email protected].

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, IN, MO, NE, PR, and SD; and countries of: Australia, Chile, Columbia, United Kingdom, and Venezula.

    Quantity

    542 units US ; 153 units International