Events

Retiro De Equipo (Recall) de Dimension Vista 500 Intelligent Lab System & Dimension Vista 1500 Intelligent Lab 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 Ltd Diagnostics Division.

¿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-2014-RN-01192-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-07
  • 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-2014-RN-01192-1
  • 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 has received customer complaints of discrepant flagged and un-flagged patient and qc results on dimension vista intelligent lab systems. siemens healthcare diagnostics has confirmed that reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.
  • Acción
    Siemens is providing additional instructions to assist laboratories in determining when the replace the reagent probe.

Device

Dimension Vista 500 Intelligent Lab System & Dimension Vista 1500 Intelligent Lab System
  • Modelo / Serial
    Dimension Vista 500 Intelligent Lab System & Dimension Vista 1500 Intelligent Lab SystemDimension Vista 500 Intelligent Lab SystemCatalogue number: 10488224Dimension Vista 1500 Intelligent Lab SystemCatalogue number: 10444802ARTG number: 174699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA