Retiro De Equipo (Recall) de TOPCON – 3D Optical Coherence Tomography 3D OCT-1 MAESTRO machines

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    In certain usage environments, when the 3d oct-1 is used over a prolonged period of time, dust can penetrate into the optical system and adhere to the surface of the lens. this dust accumulates gradually over time and this can cause a whitish shadow artefact to occur in centre of the image and potentially create a blurry background. if this occurs, the reduced image quality is an obvious anomaly noticed during clinical assessment which cannot be mistaken for patient pathology.
  • Acción
    Topcon Corporation will perform a retrofit to block the penetration points to prevent dust from entering into the optical system. In order to do this, Device Technologies will organise the return of affected machines to the manufacturer for the upgrade. A loan unit will be provided for the site whilst their machine is being upgraded. The corrective retro-fit action will be performed in a systematic manner, over a period of time due to the limited number of loan units available. Although affected systems may not exhibit any evidence of this artefact, it is recommended that all units undergo this preventative measure. Customers may continue to use their machine as usual until a loan unit is available for the site.