Events

Retiro De Equipo (Recall) de ADVIA Centaur XP Immunoassay System (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-2014-RN-00181-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-20
  • 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-00181-1
  • 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
    When the instrument cover is raised, the cover is supported by a gas spring attached at the middle of the cover. over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. this may lead to the cover falling unexpectedly.
  • Acción
    Siemens is requesting their customers to ensure that any objects placed on the cover are removed prior to opening. If the cover is unable to stay partially raised customers are requested to contact Siemens Technical Support to arrange for the gas spring to be serviced. Siemens technical support representatives will be routinely inspecting the gas spring on regular preventive maintenance cycles or service visits.

Device

ADVIA Centaur XP Immunoassay System (an in vitro diagnostic medical device (IVD))
  • Modelo / Serial
    ADVIA Centaur XP Immunoassay System (an in vitro diagnostic medical device (IVD))Siemens Material Number: 10338631ARTG Number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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