Retiro De Equipo (Recall) de ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical device (IVD).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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
    Multiple software issues have been identified for software versions v1.0 to v1.2. these issues may affect the operation and workflow of the advia centaur xpt system, and the potential exists for an apparent delay to testing. the issues are detailed in the customer letter and relate to the following: system status unknown, las communication, qc profiles, 'no primary' error, and lis specification.
  • Acción
    The software issues will be corrected in future software versions. In the interim, Siemens is providing detailed work around instructions in the customer letter. It is recommended that the letter is reviewed with the laboratory Medical Director.


  • Modelo / Serial
    ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical device (IVD).Siemens Material Number: 10711433Software versions: V1.0.1 (Bundle 1.0.912 SMN 10819704)V1.0.2 (Bundle 1.0.1086 SMN 11219806)V1.0.3 (Bundle 1.0.1108 SMN 11220781, 11219656)V1.1 (Bundle 1.1.243 SMN 11221979, 11222064)V1.2 (Bundle: SMN: 11222258, 11223813)ARTG Number: 175890
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source