Events

Retiro De Equipo (Recall) de ADVIA Centaur and ADVIA Centaur XP

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
    Recall
  • ID del evento
    RC-2015-RN-01135-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-18
  • 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-2015-RN-01135-1
  • 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
    A potential vacuum leak may occur around the glass rod sensor in the waste reservoir, caused by the gasket on the housing of the glass rod sensor sliding out of position. if the error occurs, the analyser will alarm and no results will be generated.
  • Acción
    Siemens is advising users to inspect the gasket under the Glass Rod Sensor if an error code due to low vacuum is displayed, and contact Siemens Technical Support for a replacement gasket if required. Siemens will be inspecting the Glass Rod Sensor on all analysers during the next service visit to replace if necessary. Siemens recommends discussing this notification with the laboratory director.

Device

ADVIA Centaur and ADVIA Centaur XP
  • Modelo / Serial
    ADVIA Centaur and ADVIA Centaur XPSiemens Material Number: 10321568, 10329339, 10364455ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA