BEUDAMED
    FDA Enforcement Class II Terminated

    Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart Rate, Pulse Oximetry (Sp)s), ST Segment Analysis, Arrhythmia Detection, Non Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Cardia Output (CO), Respiratory Gases, Respiration Rate and Temperature.

    Recall: Z-0107-2015 · Reported October 29, 2014

    Enforcement

    Recall Number
    Z-0107-2015
    Event ID
    69260
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 29, 2014
    Initiation Date
    July 31, 2014
    Classification Date
    October 21, 2014
    Termination Date
    April 20, 2017
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001, United States

    Description

    Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart Rate, Pulse Oximetry (Sp)s), ST Segment Analysis, Arrhythmia Detection, Non Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Cardia Output (CO), Respiratory Gases, Respiration Rate and Temperature.

    Reason

    Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function.

    Code Info

    V-Series Monitoring System, P/N: 0998-00-1800-101, 0998-00-1800-201 and DA6KB-CTO-S01.

    Distribution

    Worldwide Distribution: US (nationwide) and internationally to: Austalia, Canada, Columbia, Germany, India, Indonesia, Ireland, Israel, Kuwait, Malaysia, New Zealand, Pakistan, Russian Federation, Saudi Arabia, South Africa, Sri Lanka, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezula.

    Quantity

    2,247 units