Events

Retiro De Equipo (Recall) de ADVIA Centaur XPT System

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-2016-RN-00720-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-30
  • 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-2016-RN-00720-1
  • 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
    Siemens healthcare diagnostics has identified issues with all the advia centaur xpt system software versions that may affect the results generated by the system as described below:1. there is potential for discrepant qc and patient results. stop running the system until it is serviced if the conditions occur. the probability of this failure occurring is extremely unlikely.2. if the daily cleaning procedure (dcp) fails to complete there is potential for discrepant qc and patient results. the probability of this failure occurring is unlikely but possible if bulk fluids are not filled prior to starting the dcp.3. there is potential for delayed results noticeable to the user as either absence of results or an error posted for the sample. no erroneous results will be reported.Siemens advises the overall risk to health is low.
  • Acción
    Siemens is asking users to follow the detailed instructions in the customer letter.

Device

ADVIA Centaur XPT System
  • Modelo / Serial
    ADVIA Centaur XPT SystemSiemens Material Number: 10711433All the ADVIA Centaur XPT system software 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) and V1.1 (Bundle 1.1.243 SMN 11221979)ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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