Events

Retiro De Equipo (Recall) de Device Recall SenTec, VSign"2 Sensors

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 Sentec AG.

¿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
    62589
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2199-2012
  • Fecha de inicio del evento
    2012-07-09
  • Fecha de publicación del evento
    2012-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111100
  • 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
    Monitor, carbon-dioxide, cutaneous - Product Code LKD
  • Causa
    Sentec is recalling a number of v-sign"2 sensors due to a problem regarding configuration parameter writing during manufacturing.
  • Acción
    SenTec sent a Field Safety Notice dated July 12, 2012, via email to all affected customers. It identified the product the problem and the action needed to be taken by the customer. Customers were instructed the affected Sensors in the field must be replaced. Please locate the affected Sensors and return them to SenTec for analysis immediately. SenTec will provide you with replacement Sensors within the next three months.This notice needs to be passed on to all those who need to be aware within your organization. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Further questions please call (262 ) 594-2114.

Device

Device Recall SenTec, VSign"2 Sensors
  • Modelo / Serial
    310701 311100 311239 310996 311920 311943 311958 312132
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.
  • Descripción del producto
    SenTec, V-Sign"2 Sensors || The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).
  • Manufacturer
    Sentec AG

Manufacturer

Sentec AG
  • Dirección del fabricante
    Sentec AG, Ringstrasse 39, Therwil, Baselland Switzerland
  • Empresa matriz del fabricante (2017)
    Sentec Ag
  • Source
    USFDA