BEUDAMED
    FDA Enforcement Class II Terminated

    Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. Novii Pod - The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Novii Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Novii Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.

    Recall: Z-2588-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2588-2017
    Event ID
    77313
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MONICA HEALTHCARE LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 21, 2017
    Initiation Date
    April 28, 2017
    Classification Date
    June 14, 2017
    Termination Date
    March 1, 2018
    Address
    Interchange 25 Business Park, Bostocks Lane, Nottingham, N/A, N/A, United Kingdom

    Description

    Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. Novii Pod - The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Novii Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Novii Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.

    Reason

    Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.

    Code Info

    See attached consignee list for affected device serial numbers.

    Distribution

    The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees.

    Quantity

    4,110 (4,106 US; 4 OUS)