Events

Retiro De Equipo (Recall) de Artis zee biplane and Artis Q biplane systems

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-2017-RN-01126-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-08-28
  • 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-2017-RN-01126-1
  • 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 a screw connection in the ceiling mount consisting of 12 screws might not have been attached and fastened according to the quality standards for a specific number of artis zee/q biplane systems. the connection is located within the rotation unit of the second plane.If such screws are not fully tightened in accordance with the specified values, single screws between the c-arm structure of the second plane and its ceiling carriage may become loose. if various screws become loosened over time, this may lead to a recognisable wobble of the c-arm, especially during fast movements. this may result in an acquired image/3d which does not allow for clinical appraisal, resulting in additional x-ray exposure for a patient.There is also the remote possibility that if, after an extended time period, all screws become loosened, parts of the second plane mechanics may become detached from the ceiling carriage of the system, and could hurt the patient and/or personnel.
  • Acción
    Siemens will arrange for all potentially affected systems to be examined. All affected systems will be modified so as to have the screws tightened.

Device

Artis zee biplane and Artis Q biplane systems
  • Modelo / Serial
    Artis zee biplane and Artis Q biplane systemsCatalogue Numbers: 10094141 and 10848282ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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