Events

Retiro De Equipo (Recall) de Advantx Legacy/Legacy-D Radiographic and Fluoroscopic System

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-00198-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-08
  • 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-2017-RN-00198-1
  • 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
    There have been reported incidents of a patient step detaching from the table. a fall from a patient step detaching while in use could result in an injury to a patient or operator. there have been no injuries reported as a result of this issue.
  • Acción
    GE Healthcare will correct all affected products and a GE Healthcare representative will contact affected customers to arrange for the correction. In the interim, customers are advised to check the table tub bottom pan and patient step hardware for any looseness. Discontinue use of the patient step in case of any looseness and immediately contact the GE service representative. This action has been closed-out on 1/03/2018.

Device

Advantx Legacy/Legacy-D Radiographic and Fluoroscopic System

Manufacturer

GE Healthcare Australia Pty Ltd