Events

Retiro De Equipo (Recall) de Dimension Vista 500 and Dimension Vista 1500 using software versions 3.5.1 and 3.6 - Clinical chemistry analyser. 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 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-2013-RN-00649-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-28
  • 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-2013-RN-00649-1
  • 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 has confirmed that, under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a qc or calibrator product from a vista vial. if two samples are dispensed into the same aliquot well, the first sample will always be qc or calibrator from a vista vial. patient sample will never be dispensed into an aliquot well that contains another patient sample.
  • Acción
    In the event of an instrument reset, end users are requested to check if there are any QC or calibration tests pending. If there are QC or calibrations pending a software restart is necessary before resuming patient processing. If there is no QC or calibration pending reset or troubleshoot the instrument as per the Operators Guide. A software update will be provided as a permanent fix.

Device

Dimension Vista 500 and Dimension Vista 1500 using software versions 3.5.1 and 3.6 - Clinical che...
  • Modelo / Serial
    Dimension Vista 500 and Dimension Vista 1500 using software versions 3.5.1 and 3.6 - Clinical chemistry analyser. An in vitro diagnostic medical device (IVD)Siemens Material Numbers: 10488224 and 10444802ARTG Number: 174699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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