Events

Retiro De Equipo (Recall) de Device Recall Neuro Works

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Natus Neurology DBA Excel Tech., Ltd. (XLTEK).

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    72763
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0581-2016
  • Fecha de inicio del evento
    2015-11-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142174
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Full-montage Standard Electroencephalograph - Product Code GWQ
  • Causa
    During an internal testing, natus medical incorporated, identified that in neuro works 8.1 with quantum hardware, the incoming signal is displayed with reversed polarity.
  • Acción
    The firm, Natus Neurology, sent an "Urgent Medical Device Correction Notification" letter on 11/11/2015. The letter described the the problem, the product involved in the recall and actions to be taken. Natus will provide further information once an updated software is released. The consignees were instructed to complete and return the confirmation form by mail to Senior Manager Quality and Regulatory Affairs, Excel-Tech, Ltd (XLTEK) Division, Natus Medical Incorporated, 2568 Bristol Circle, Oakville, ON L6H 5S1 or by email to :ots@natus.com. If you have any questions, contact Senior Manager Quality and Regulatory Affairs at 905-287-5055 or email: sanjay.mehta@natus.com.

Device

Device Recall Neuro Works
  • Modelo / Serial
    Serial Number 013926020008 013926020009 013926020006 013926020016 013926020014 013926030024 013926030031 013926020001 013926020004 013926030059 013926030060 013926030074 013926030075 013926030052 013926030017 013926030018 013926030021 013926030053 013926030101 013926030058 013926030019 013926030038 013926030039 013926030044 013926020015 013926030097 013926020013 013926030055 013926030056 013926030081 013926030096 013926030078 013926030048 013926030057 013926030064 013926030047 013926030027 013926030025 013926030042 013926030023 013926030030 013926030036 013926030026 013926030050 013926030080 013926030099 013926030035 013926030046 013926030049 013926030073 013926030020 013926030092 013926030040 013926030041 013926030061 013926030062
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US Distribution including states of: AL, AZ, AR, CO, FL, GA, MD, MA, MN, MS, NJ, NY, OH, SC, TN, TX and UT; and countries of: INDIA, KOREA, SPAIN, SWITZERLAND, THAILAND, UNITED KINGDOM, and CANADA. .
  • Descripción del producto
    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. || The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
  • Manufacturer
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Manufacturer

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
  • Dirección del fabricante
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK), 2568 Bristol Cir, Oakville Canada
  • Empresa matriz del fabricante (2017)
    Natus Medical Incorporated
  • Source
    USFDA