BEUDAMED
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    VIKING

    FDA Adverse Event
    Other ·CAREFUSION 209 INC.·Product code IKN·March 6, 2012

    NICOLETONE VEEG 44 CHANNEL ETERNET DIGITAL VI

    FDA Adverse Event
    Other ·CAREFUSION 209 INC.·Product code GWQ·March 7, 2012

    NICOLETONE VEEG 44 CHANNEL ETHERNET DIGITAL VI

    FDA Adverse Event
    Other ·CAREFUSION 209 INC.·Product code GWQ·March 7, 2012

    NICOLET NIC VUE

    FDA Adverse Event
    Malfunction ·CAREFUSION 209, INC.·Product code GWQ·December 9, 2009

    ALLIGATOR CLIP LEAD WIRE

    FDA Adverse Event
    Other ·CAREFUSION 209 INC.·Product code GXY·March 9, 2011

    SONARA

    FDA Adverse Event
    Other ·CAREFUSION 209 INC·Product code IYN·March 9, 2011

    VIKING

    FDA Adverse Event
    Other ·CAREFUSION 209 INC.·Product code ETN·March 9, 2011

    SONARA

    FDA Adverse Event
    Other ·CAREFUSION 209 INC.·Product code IYN·April 19, 2011

    NICOLETONE SOFTWARE WITH CORTICAL STIMULATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION 209 INC.·Product code GYC·October 7, 2011

    NICOLETONE LTM CENTRAL MONITOR

    FDA Adverse Event
    Other ·CAREFUSION 209 INC.·Product code GWQ·November 16, 2011

    NICOLET LTM

    FDA Adverse Event
    CAREFUSION 209 INC.·Product code GWQ·August 11, 2010

    Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200, 688-624300, 842-687900, 672-610800F. Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe.

    FDA Recall
    Terminated ·CareFusion 209 Inc.·Product code GYC·October 5, 2011

    Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe.

    FDA Recall
    Terminated ·CareFusion 209 Inc.·Product code GYC·October 5, 2011

    NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid the hospital in tracking patient data from collection to review to archive. The NicVue Software includes the following features and intended uses: Launch Applications, Enter patient information, Import/Export patient information from the Hospital Information System, Move data files, Archive data files on DVD or CDROM.

    FDA Recall
    Terminated ·CareFusion 209 Inc.·Product code OUG·December 16, 2011

    NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: 828-056600 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe.

    FDA Recall
    Terminated ·CareFusion 209 Inc.·Product code GYC·October 5, 2011

    SLEEPNET

    FDA Adverse Event
    Other ·CAREFUSION 211, INC.·Product code BZD·November 7, 2011

    CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.

    FDA Enforcement
    Class I ·Terminated·CareFusion 203, Inc.·July 25, 2012

    CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.

    FDA Enforcement
    Class I ·Terminated·CareFusion 203, Inc.·October 1, 2014

    LTV 1200 VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·November 16, 2016

    LTV

    FDA Adverse Event
    Death ·CAREFUSION 203, INC·Product code CBK·September 10, 2015