Events

Retiro De Equipo (Recall) de CARESTATION 620

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
    15861
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-11-03
  • 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
    The following issue is being addressed by ge healthcare file no. fmi 34086: ge healthcare has recently become aware that an incomplete seal can exist between the co2 absorber and the breathing circuit co2 bypass port assembly of the carestation 600 series systems. an incomplete seal can allow rebreathing of patient gases that have bypassed the co2 absorbent material and could result in unintended elevated levels of inspired co2 (fico2) which could lead to hypercarbia. there have been no injuries reported as a result of this issue.

Device

CARESTATION 620
  • Modelo / Serial
    Model Catalog: 1012-9620-000 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 1012-9650-000 (Lot serial: > 10 numbers contact mfg.)
  • Descripción del producto
    CARESTATION 620;CARESTATION 650
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)