Events

Retiro De Equipo (Recall) de Artis zeego systems with a C - arm (Fluoroscopic X-ray 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 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-01112-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-17
  • 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-01112-1
  • 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 have identified that a cable inside the c - arm of affected systems may have been routed in an inappropriate manner and there is a potential that with increase wear the cable inside the c - arm may break. a cable break will result in restricted functionality or system failure.
  • Acción
    A Siemens service technician will contact affected customers to organise the modification of the cable routing to prevent the issue from occurring. This action has been closed-out on 14/07/2016.

Device

Artis zeego systems with a C - arm (Fluoroscopic X-ray systems)
  • Modelo / Serial
    Artis zeego systems with a C - arm (Fluoroscopic X-ray systems)C - arm serial number range: 1000 to 1599ARTG number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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