Events

Retiro De Equipo (Recall) de AW VOLUMESHARE 4 - THORACIC VCAR

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
    91725
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-05-06
  • 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
    When using the summary table feature on thoracic vcar to display data incorrect patient name will be displayed if the user does not exit the application in between the analysis of two consecutive patients. if the user did not exit the application the correct imaging study will appear and the data on the summary table will contain the results of the current patient imaging study however the previous patient name will be displayed on the summary table. this summary result may be separated from the remainder of the ct imaging exam if it is printed on film or paper and incorrectly inserted in another patient's file. this issue may cause confusion and possible incorrect assessment. no adverse event has been reported related to this issue.

Device

AW VOLUMESHARE 4 - THORACIC VCAR

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)