Events

Retiro De Equipo (Recall) de Device Recall Eclipse Oxygen System

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 Sequal Technologies Inc.

¿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
    53952
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0567-2010
  • Fecha de inicio del evento
    2009-10-01
  • Fecha de publicación del evento
    2009-12-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86920
  • 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
    Portable Oxygen Generator - Product Code CAW
  • Causa
    Unit may shut down when operating from the power cartridge. a temporary power interruption would cause the unit to sound an alarm and shut down. if the patient does not have access to an alternate supply of oxygen or access to ac or dc power, this may lead to shortness of breath, hypoxia, or in some patients may cause serious health consequences.
  • Acción
    The recall notification was initiated on November 12, 2009 with the firm forwarding a "Medical Device Correction" letter to all of the affected consignees via US Postal Service for US Consignees and FedEx for Foreign Consignees. The Medical Device Correction Letter contained the following: (1) Medical Device Correction Letter; (2) List of Serial Number affected that were distributed to the Provider; (3) Reply Card that the Provider will be requested to send back regarding receipt notification of the Medical Device Correction Letter and confirming that they have the affected product; (4) Additional Medical Device Correction Letters for Providers to distribute to their patients. The Medical Device Correction Letter informed the consignees of the reason for recall, the hazard involved and the actions that were required. For further details or information, consignees were instructed to contact SeQual Technical Support at 1-800-826-4610 from 8:00 AM to 5:00 PM PST.

Device

Device Recall Eclipse Oxygen System
  • Modelo / Serial
    Serial Numbers: All Serial Numbers affected for units manufactured June 2006 - January 2008.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- Including countries of USA, ARGENTINA, AUSTRIA, BAHAMAS, BERMUDA, CANADA, CHILE, COLUMBIA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, ITALY, ISRAEL,JAPAN, JORDAN, KUWAIT, MALTA, NETHERLANDS, POLAND, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Descripción del producto
    SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 || Indicated for the administration of supplemental oxygen.
  • Manufacturer
    Sequal Technologies Inc

Manufacturer

Sequal Technologies Inc
  • Dirección del fabricante
    Sequal Technologies Inc, 11436 Sorrento Valley Rd, San Diego CA 92121
  • Empresa matriz del fabricante (2017)
    Sequal Technologies
  • Source
    USFDA