Events

Retiro De Equipo (Recall) de Specular Microscope SP-1P (non-invasive photographic microscope)

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
    Recall
  • ID del evento
    RC-2014-RN-00771-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-10
  • 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-00771-1
  • 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
    It has come to the attention of topcon corporation that during the analysis of large corneal endothelial cells captured by the “specular microscope sp-1p” the unit may provide higher than actual cell count. topcon corporation found that in some cases when an image with large corneal endothelial cells (approximate cell density 1,500 cells/mm2 or less) was analysed the cell density may be higher due to a smaller cell area. consequently, when an image with large corneal endothelial cells is analysed by the current auto-analysis software, it detects the core of the cell as a cell wall, hence one cell would be recognised as two or more cells.
  • Acción
    Device Technologies is providing a software upgrade to improve the detection of large size cells. End users are advised to evaluate the examination result of the Specular Microscope SP-1P not only with the resulting cell count, but also by reviewing the captured image while awaiting the software upgrade. This action has been closed-out on 19/02/2016.

Device

Specular Microscope SP-1P (non-invasive photographic microscope)

Manufacturer

Device Technologies Australia Pty Ltd