Events

Retiro De Equipo (Recall) de TRUSAT OXIMETER - WITH EXPENSION OPTION

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    84937
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2010-02-24
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Under certain conditions enclosure leakage current exceeds allowed limits. the measured enclosure currents can be 8 - 10ma. maximum allowed value for enclosure leakage current for single fault condition is 0.5ma according to iec60601-1:2005.

Device

TRUSAT OXIMETER - WITH EXPENSION OPTION
  • Modelo / Serial
    Model Catalog: 6051-0000-191 (Lot serial: >100 NUMBERS); Model Catalog: 6051-0000-193 (Lot serial: >100 NUMBERS); Model Catalog: 6051-0000-191 (Lot serial: CONTACT); Model Catalog: 6051-0000-193 (Lot serial: CONTACT); Model Catalog: 6051-0000-191 (Lot serial: MANUFACTURER); Model Catalog: 6051-0000-193 (Lot serial: MANUFACTURER); Model Catalog: 6051-0000-190 (Lot serial: >10 NUMBERS); Model Catalog: 6051-0000-192 (Lot serial: >10 NUMBERS); Model Catalog: 6051-0000-190 (Lot serial: CONTACT); Model Catalog: 6051-0000-192 (Lot serial: CONTACT); Model Catalog: 6051-0000-190 (Lot serial: MANUFACTURER); Model Catalog: 6051-0000-192 (Lot serial: MANUFACTURER)
  • Descripción del producto
    TRUSAT OXIMETER - WITH EXPENSION OPTION
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)