Events

Retiro De Equipo (Recall) de Giraffe Incubator and Giraffe OmniBed with Servo Oxygen Control SystemManufactured between August 1 2012 and December 20 2012

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty Ltd.

¿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
    RC-2013-RN-00023-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-01-08
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00023-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    When the giraffe omnibed and giraffe incubator is powered "on" or there is a recovery from power failure, the oxygen set point or radiant heater set point (values that are entered by the clinician) may be overwritten due to a potential overwriting of stored information associated with the display printed circuit board.
  • Acción
    GE Healthcare is advising hospitals may continue to use the affect product, however, all set points must be confirmed when powering 'on' the Giraffe microenvironment or when recovering from a power failure event. A software update will be provided by GE Healthcare to correct the issue.

Device

Giraffe Incubator and Giraffe OmniBed with Servo Oxygen Control SystemManufactured between August...

Manufacturer

GE Healthcare Australia Pty Ltd