Events

Retiro De Equipo (Recall) de Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System (2RT)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ellex Medical 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-00301-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-22
  • 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-2016-RN-00301-1
  • 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 manufacturer has identified a potential defect in the fixed laser eye safety filter assembly for the above laser systems. under certain conditions there is potential for the glass of the safety filter optics to crack on their lower edge due to pressure applied on them by their retaining plate which in turn could damage the laser safety coating on the optics.The safety filter is located on the binocular mount of the delivery head, and is in the user’s optical viewing path and as such provides protection to the user’s eyes from any diffused reflected laser light during the laser treatment.There is a risk associated that if the above failure mode occurs, there is a remote possibility that during laser treatment the user could be exposed to any diffused reflected laser light.
  • Acción
    Ellex Medical is advising users to check the affected devices to see if there is any green laser light visible while firing the laser. If so, remove the device from use and notify Ellex. Ellex will be replacing the filters on all affected systems with a newly designed filter. This action has been closed-out on 27/01/2017.

Device

Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System ...
  • Modelo / Serial
    Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System (2RT) Model Numbers: LP5532 and LR1532Multiple Serial Numbers affectedARTG Number: 106758 and 224484
  • Manufacturer
    Ellex Medical Pty Ltd

Manufacturer

Ellex Medical Pty Ltd