BEUDAMED
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    EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

    FDA Recall
    Terminated ·EEG Info·Product code HCC·November 15, 2012

    ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.

    FDA Recall
    Terminated ·LIFELINES NEURO COMPANY·Product code GWQ·October 11, 2019

    ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended to be used for such studies as electroencephalogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.

    FDA Recall
    Terminated ·LIFELINES NEURO COMPANY·Product code GWQ·October 11, 2019

    BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne. Nicolet Biomedical, Inc.

    FDA Recall
    Terminated ·Nicolet Biomedical Div of Viasys Healthcare·Product code GWQ·July 17, 2007

    NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display data

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code GWQ·September 11, 2015

    Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.

    FDA Recall
    Terminated ·Natus Neurology Incorporated·Product code GWL·February 27, 2013

    Nicolet Ambulatory EEG

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code OLV·February 1, 2018

    XLTEK EMU40EX EEG Headbox

    FDA Recall
    Terminated ·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code GWQ·May 15, 2018

    Skull Anchor Bolts

    FDA Recall
    Terminated ·Ad-Tech Medical Instrument Corporation·Product code GZL·June 18, 2019

    Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes

    FDA Recall
    Terminated ·Ad-Tech Medical Instrument Corporation·Product code GYC·June 18, 2019

    Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes

    FDA Recall
    Terminated ·Ad-Tech Medical Instrument Corporation·Product code GZL·June 18, 2019

    NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central control room.

    FDA Recall
    Terminated ·Cardinal Health NeuroCare Division·Product code GWQ·June 13, 2008

    Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060; Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a built-in pulse oximeter, body position sensor, snore monitor, chest, abdominal and air flow transducers and electrode array for EEG, EMG and EOG)

    FDA Recall
    Terminated ·Bio-Logic Systems Corp·Product code GWQ·February 26, 2007

    Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medical point-of-care device designed to warm blood and IV fluids.

    FDA Recall
    Terminated ·Enginivity LLC·Product code LGZ·March 23, 2009

    Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.

    FDA Recall
    Terminated ·Alpha Omega Engineering·Product code GZL·September 4, 2018

    NicoletOne photic adapter cable 085-463700

    FDA Recall
    Terminated ·Cardinal Health NeuroCare Division·Product code GWQ·June 5, 2008

    Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)

    FDA Recall
    Terminated ·Blackrock Microsystems, LLC·Product code GWL·August 10, 2016

    Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)

    FDA Recall
    Terminated ·Blackrock Microsystems, LLC·Product code GWL·August 10, 2016

    BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code GXY·November 8, 2011

    EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.

    FDA Recall
    Terminated ·Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario·Product code GWE·January 2, 2015