Events

Retiro De Equipo (Recall) de ARTIS Zeego (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 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-2014-RN-00383-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-01
  • 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-00383-1
  • 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 healthcare has determined that the crimping of motor connectors a1 to a3 may have been incorrectly carried out. incorrectly executed crimping where the crimping tool was used on the wrong point of the crimp contact has led to substandard contacting. the resulting increase in interference resistance can cause heat build up and potentially lead to scorching of the corresponding cables.
  • Acción
    Siemens will be inspecting the connectors to ensure they are correctly crimped at the A1 to A3 motor terminals. A Siemens representative will be in touch to schedule the visit.

Device

ARTIS Zeego (Fluoroscopic angiographic x-ray system)
  • Modelo / Serial
    ARTIS Zeego (Fluoroscopic angiographic x-ray system)Serial number of the motor connectors lower than 946925
  • Manufacturer
    Siemens Ltd

Manufacturer

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