Events

Retiro De Equipo (Recall) de AXIOM Artis, Artis zee and Artis Q/Q.zen system (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-01004-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-28
  • 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-2016-RN-01004-1
  • 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 identified that contaminants in the form of biomass can develop in the cooling system of artis systems, which can result in damage to the pump system. the presence of contaminants in the tube cooling circuit could impair the performance of the pump. the tube assembly can become overheated so that no radiation can be released. there is a risk that an ongoing procedure cannot be continued, however, the probability of this occurring is unlikely.
  • Acción
    Siemens is advising users that a technician will be installing an additional external filter in the cooling water circuit to prevent the failure of the pump system. A further correction will be implemented to prevent the development of biomass in the cooling circuit as a permanent correction. Siemens is advising that there is no requirement to re-examine patients.

Device

AXIOM Artis, Artis zee and Artis Q/Q.zen system (fluoroscopic angiographic x-ray system)
  • Modelo / Serial
    AXIOM Artis, Artis zee and Artis Q/Q.zen system (fluoroscopic angiographic x-ray system)Catalogue/Lot Numbers: 5904433, 5904649, 5904466, 5904441, 5904656, 7728350, 7007755, 7412807, 7727717, 7728392, 7413078, 5917054, 7555373, 7555357, 7008605, 7555365, 10502501, 10848280, 10848353, 10502502, 10848281, 10848354, 10502505, 10848283, 10502504, 10848282, 10848355, 10502507, 10094135, 10094142, 10094137, 10094143, 10094141, 10094139, 10280959ARTG Numbers: 102173, 27395, 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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