Events

Retiro De Equipo (Recall) de Topcon 3D Optical Coherence Tomography 3D OCT-1 Maestro systems

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Topcon Corporation.

¿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
    18685
  • Fecha de inicio del evento
    2015-06-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • 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
    Product to be modified

Device

Topcon 3D Optical Coherence Tomography 3D OCT-1 Maestro systems
  • Modelo / Serial
    Model: TOP-470109800, Affected: Serial number range: 105104 to 105701
  • Manufacturer
    Topcon Corporation

Manufacturer

Topcon Corporation