Events

Retiro De Equipo (Recall) de AXIOM Artis, Artis zee and Artis Q/Q.zen (fluoroscopic angiographic x-ray 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-00229-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-04
  • 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-00229-1
  • 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
    Due to a leak in the cooling system, fluids could seep into the equipment cabinet. this leak can occur sporadically in the affected systems. the issue was identified during regular field observations. in this case, there was a leak in the hose connectors. loss of coolant can result in cooling system failure, and in a worst case scenario, this leak can cause system failure.
  • Acción
    Siemens are advising users that service personnel will be replacing the affected couplings in order to prevent the issue from occurring.

Device

AXIOM Artis, Artis zee and Artis Q/Q.zen (fluoroscopic angiographic x-ray system)
  • Modelo / Serial
    AXIOM Artis, Artis zee and Artis Q/Q.zen (fluoroscopic angiographic x-ray system)Catalogue Numbers: 7555365, 10094141, 10094139, 10094137, 10094135, 10280959, 10848281, 10848280, 10848282, 7413078, 7412807, 7008605, 10848355, 7728392, 7555357, 7727717ARTG Numbers: 102173 and 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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