Events

Retiro De Equipo (Recall) de Ceiling system for Artis Zee System (Fluoroscopic angiographic digital 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 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-2013-RN-01163-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-20
  • 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-2013-RN-01163-1
  • 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
    Cables in the cable harness of the ceiling carriage may have received wear and tear or damage resulting in loss of system movement or loss of complete functionality. siemens technical specialists have advised that this issue could result in a limited or total loss of functionality with regards to the system movement. the cable damage caused by this issue would only affect system movement, not the imaging. however, as this type of system may be used during procedures for the placement of catheters, pacemakers, transcatheter aortic valve implantations etc. the loss of system movement may limit the available imaging during this type of procedure.
  • Acción
    Siemens is inspecting all potentially affected cables and installing an additional cable guide system to prevent wear if necessary.

Device

Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)
  • Modelo / Serial
    Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)Catalogue Number: 10094137Serial Numbers: 146367, 146674, 146718, 146880, 146910, 146926, 146967, 147054, 147092, 147095, 147101, 147102, 147518All systems equipped with a ceiling stand with serial numbers from 10701 to 11557ARTG Number: 120177
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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