Events

Retiro De Equipo (Recall) de ADVIA Centaur XPT

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 Siemens Healthcare Diagnostics Inc.

¿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
    19972
  • Fecha de inicio del evento
    2016-06-24
  • 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: Siemens Healthcare (NZ) Ltd, 55 Hugo Johnston Drive, Penrose, Auckland
  • Causa
    Certain reservoirs have been manufactured with walls that are below the nominal specification, potentially causing a following problem when the reservoir is under vacuum. the seam at the bottom of certain reservoirs could crack slightly and have a slight leak., the fitting at the bottom of the reservoir could exhibit some leaks at the interface between the reservoir and the fitting., if a leak occurs due to a crack in the bottom of the reservoir, foaming may occur in the glass jar in the bulk fluid drawer and cause the instrument to stop with vacuum low error # 01 600 13 24.
  • Acción
    Manufacturer to issue advice regarding use

Device

ADVIA Centaur XPT

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA