Events

Retiro De Equipo (Recall) de Artis systems with Artis tables

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-01506-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-14
  • 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-01506-1
  • 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 been made aware of an issue with the artis systems with artis tables. the artis table top carriage is mounted on top of the table base and fixed with a bolt. a snap right is used to secure the bolt. in the case of a missing or wrongly installed snap ring the bolt could slide out of its base, and the table top carriage will slide to the floor.
  • Acción
    Siemens Healthcare will be in contact with affected customers to arrange for a service to ensure the snap ring has been installed correctly.

Device

Artis systems with Artis tables
  • Modelo / Serial
    Artis systems with Artis tablesCatalogue number – Artis systems – 5904433, 7008605, 7412807, 7413078, 7555357, 7555365, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848355, 10848600, 10849000 in combination with various different material number tables.ARTG: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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