Events

Retiro De Equipo (Recall) de Leica ASP 300S Analyser

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 Leica Instruments Singapore Pte 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
    18963
  • Fecha de inicio del evento
    2015-08-12
  • 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: Leica Microsystems Pty Ltd, New Zealand Branch, 3/33 Spartan Road, Takanini, Auckland 2105
  • Causa
    The manufacturer recently became aware that these devices have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm not to function correctly in the case of an instrument failure., if there is an instrument failure during processing and the remote alarm is relied upon then 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
    Product to be modified

Device

Leica ASP 300S Analyser

Manufacturer

Leica Instruments Singapore Pte Ltd