Events

Retiro De Equipo (Recall) de Harmonie software versions 5.1 uo to 6.2e :

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 Stellate Systems.

¿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
    64594
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1080-2013
  • Fecha de inicio del evento
    2009-04-06
  • Fecha de publicación del evento
    2013-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116691
  • 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
    The firm is initiating this recall because the implied or stated indications in their labeling associated with harmonie software have not yet been cleared by the fda for sale in the usa.
  • Acción
    Stellate sent an "DEVICE CORRECTION" letter dated April 6, 2009, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Customers were instructed to check the product code referenced in the service manual to verify if your system is affected and check in "Help" & "About Harmonie" in the menu to determine the software version on these systems. Stellate will shortly release updates to disable the noted features that were present in your particular version of the Harmonie software and revise labeling and Instructions for Use. All customers in possession of an affected system will be contacted by our Customer Support team to set up an appointment for installation of the updated version. If you have any questions or concerns regarding this notification, please do not hesitate to call our customer support line at 1-888-742-1306.

Device

Harmonie software versions 5.1 uo to 6.2e :
  • Modelo / Serial
    Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP Model HSYS-REC-DUO-PPC Model HSYS-REC-DUO-PPC Models HSYS-RDR-D, HSYS-RDR-T
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, DE, FL, HI, IA, IN, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, OR, PA, RI, SC, TX, VA, VT, WI, WV, and WY; and the countries of: Argentina, Australia, Bahrain, Brasil, Canada, China, Denmark, Finland, France, Germany, Greece, Haiti, Hong Kong, Hungary, Indonesia, Iran, Israel, Italy, Japan, Korea, KSA, Mexico, Netherlands, Norway, Pakistan, Portugal, Rep. DE Panama, Saudi Arabia, Spain, Switzerland, Taiwan ROC, Thailand, Turkey, and United Kingdom.
  • Descripción del producto
    Harmonie software versions 5.1 uo to 6.2e : || Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) || Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ,
  • Manufacturer
    Stellate Systems

Manufacturer

Stellate Systems
  • Dirección del fabricante
    Stellate Systems, 345 Victoria Avenue, Suite 300, Westmount Canada
  • Source
    USFDA