Events

Retiro De Equipo (Recall) de Kenex suspension arm with radiation shield and/or surgical lamp

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-2014-RN-00407-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-04
  • 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-2014-RN-00407-1
  • 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 an improper installation of the kenex suspension arm of a radiation shield. the suspension arm was not installed by ge healthcare per specified installation requirements. there is no deficiency associated with the kenex suspension arm. there has been one reported incident of a radiation shield falling from the ceiling causing a minor injury.
  • Acción
    GE Healthcare is inspecting all affected systems to verify that the Kenex suspension radiation shields and surgical lamps are properly installed. A GE representative will contact customers to arrange for the inspection. Any affected systems will be corrected.

Device

Kenex suspension arm with radiation shield and/or surgical lamp

Manufacturer

GE Healthcare Australia Pty Ltd