Events

Retiro De Equipo (Recall) de Device Recall Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module

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 Sechrist Industries 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
    52796
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0208-2013
  • Fecha de inicio del evento
    2008-08-28
  • Fecha de publicación del evento
    2012-11-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84024
  • 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
    Chamber, hyperbaric - Product Code CBF
  • Causa
    Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with electronic control modules in order to correct a software bug that could potentially affect the performance of the chamber.
  • Acción
    Sechrist Industries contacted consignees by phone to notify them of a software upgarde and to schedule appointments to perform the required field upgrades. An approximate summary of the phone notification is provided below. "I am contacting you to notify you of a field upgrade we are performing on our hyperbaric chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of your chamber. The upgrade includes the installation of a new motherboard with revised software, a reset switch, and the exchange of other control panel components. The process will take approximately 2.5 hours and will be performed at no charge to you." For questions regarding this recall call 714-579-8400.

Device

Device Recall Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module
  • Modelo / Serial
    Serial Numbers: 330001-330069, 330071, 330072, 330074, 330075.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
  • Descripción del producto
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER || The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
  • Manufacturer
    Sechrist Industries Inc

Manufacturer

Sechrist Industries Inc
  • Dirección del fabricante
    Sechrist Industries Inc, 4225 E La Palma Ave, Anaheim CA 92807
  • Empresa matriz del fabricante (2017)
    Sechrist Industries Inc.
  • Source
    USFDA