Events

Retiro De Equipo (Recall) de Star Excimer Laser System (used to surgically correct visual refractive error in corneal surgery)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AMO 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-2013-RN-01093-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-25
  • 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-2013-RN-01093-1
  • 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 is aware of an issue that has the potential to result in loss of illumination due to unexpected failure of a component under high use conditions of the oblique and ring illumination lamps. this issue can be traced to overheating of a specific component found in a limited amount of star system, which can result in a burning smell coming from the laser system.
  • Acción
    Abbott Medical Optics (AMO Australia) is advising users that the printed circuit board of the affected units will be replaced prior to 31 January 2014. AMO is advising users to contact the AMO service representative in the case a system has a loss of illumination.

Device

Star Excimer Laser System (used to surgically correct visual refractive error in corneal surgery)
  • Modelo / Serial
    Star Excimer Laser System (used to surgically correct visual refractive error in corneal surgery)Model Number: S4 IRSerial Number: 9271ARTG Number: 120575
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd