Events

Retiro De Equipo (Recall) de Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon Visera Elite, Light Source Xenon Exera III, High Flow Co2 Insufflator, Scopeguide Unit & Video System Center (components or parts of endoscopes)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Olympus 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-00859-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-08
  • 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-2014-RN-00859-1
  • 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
    The power switch of the abovementioned models may become stuck after extended use and the following may occur: 1) when the power switch is stuck whilst the unit is ‘on’, the unit cannot be turned ‘off’ using the power switch on the model. 2) when the power switch is stuck whilst the unit is ‘off’, the unit cannot be turned ‘on’ using the power switch on the unit. this issue could result in a delay of diagnosis or treatment procedure as the device would no longer be operational a replacement device would be needed to complete treatment or diagnosis.
  • Acción
    An Olympus Field Service Technician will replace the power switch on all the affected units. This action has been closed-out on 18/07/2016.

Device

Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon ...
  • Modelo / Serial
    Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon Visera Elite, Light Source Xenon Exera III, High Flow Co2 Insufflator, Scopeguide Unit & Video System Center (components or parts of endoscopes)Model Numbers: OTV-S190, CV-190, 3DV-190, CLV-S190, CLV-190, UHI-4, UPD-3 & CV-170ARTG Numbers: 120819, 120820, 194240, 211802, 219880 & 216644
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd