Events

Retiro De Equipo (Recall) de Rotating IV Pole, used with Giraffe OmniBed Carestation, Giraffe Incubator Carestation Giraffe OmniBed, Giraffe Warmer, Panda Warmer, Giraffe Incubator, Care Plus Incubator, IWS, and Giraffe Shuttle.

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-2017-RN-01512-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-18
  • 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-2017-RN-01512-1
  • 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
    Ge healthcare has recently become aware of the potential for the rotating iv pole to fall. a fall could result in an injury to a bystander holding the patient or to the operator.There have been no reported injuries as a result of this issue.
  • Acción
    GE Healthcare is advising hospitals to discontinue use of the affected Rotating IV poles and remove from service. Place affected Rotating IV poles in a quarantine marked area. A GE Service Representative will contact customers to arrange for the removal & replacement of a new IV pole.

Device

Rotating IV Pole, used with Giraffe OmniBed Carestation, Giraffe Incubator Carestation Giraffe Om...
  • Modelo / Serial
    Rotating IV Pole, used with Giraffe OmniBed Carestation, Giraffe Incubator Carestation Giraffe OmniBed, Giraffe Warmer, Panda Warmer, Giraffe Incubator, Care Plus Incubator, IWS, and Giraffe Shuttle.Part Number: 6600-0851-800Multiple Affected Lot NumbersARTG Number: 168674, 139289
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd