Retiro De Equipo (Recall) de Savion ED Trolley (mobile stretcher)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Huntleigh Healthcare 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-2016-RN-00930-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-12
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    It has been determined that the a number of trolleys with the affected serial numbers have been supplied to arjohuntleigh with the incorrect tbb6 battery. this may result in a burning smell when connected to mains power. there have been no reports of injuries as a result of this issue.
  • Acción
    ArjoHuntleigh has advised users to remove the stretchers from use. The batteries will be replaced by unaffected stock as a permanent correction. This action has been closed-out on 03/08/2016.

Device

  • Modelo / Serial
    Savion ED Trolley (mobile stretcher)Model Number: ES-711XSerial Number: 20150811XXXX, 201508170001 and 201508170002ARTG Number: 225146
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA