BEUDAMED
    FDA Recall Terminated

    Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.

    Recall: Z-0528-2013 · Initiated September 24, 2012

    Recall

    Recall Number
    Z-0528-2013
    Event Number
    63652
    Firm
    Mindray DS USA, Inc. d.b.a. Mindray North America
    FEI Number
    2221819
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 24, 2012
    Posted
    December 17, 2012
    Terminated
    August 15, 2013
    Address
    800 MacArthur Blvd., Mahwah, NJ, 07430

    Description

    Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.

    Reason

    Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.

    Action

    Mindray issued an "Urgent: V Series Monitoring System Corrective Action" letter dated 9/24/2012 via certified mail with return receipt verification to all hospitals. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 to arrange for relplacement of the affected product. For questions regarding this recall call 201-995-8407.

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia.

    Quantity

    206 units (180 units domestic, 26 units foreign)