Events

Retiro De Equipo (Recall) de Kenex ceiling-suspended radiation shields and surgical lamps

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-2015-RN-00208-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-03-12
  • 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-2015-RN-00208-1
  • 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 become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. the pendent system was not installed per specified installation requirements. there has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.This action is an update of the product correction - rc-2014-rn-00407-1.
  • 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. This actio has been closed-out on 03/08/2016.

Device

Kenex ceiling-suspended radiation shields and surgical lamps

Manufacturer

GE Healthcare Australia Pty Ltd