Retiro De Equipo (Recall) de Leica ASP200S & Leica ASP300S. In vitro diagnostic medical devices (IVD)(Histology sample processing instruments)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Leica Microsystems 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
    Leica microsystems recently became aware that affected devices have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure. the missing alarm signal could lead to suboptimal quality tissue processing. in some cases, a re-biopsy of the patient could be necessary in order to obtain another viable tissue sample.
  • Acción
    A Leica Service Engineer will correct the internal wiring and check the remote alarm functionality.


  • Modelo / Serial
    Leica ASP200S & Leica ASP300S. In vitro diagnostic medical devices (IVD)(Histology sample processing instruments)Leica ASP200S Product Code: 14048043625Serial Numbers: 5329, 5448, 5528, 5707Leica ASP300SProduct Code: 14047643514Serial Numbers: 5361, 5639, 5721, 5872, 6057
  • Manufacturer