Events

Retiro De Equipo (Recall) de Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assembly

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-2015-RN-00550-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-22
  • 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-2015-RN-00550-1
  • 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
    Due to a production fault in a specific production lot of the triple-focus x-ray tube assembly, there is a possibility that the "small focus" may fail. if this occurs, no further radiation release will be possible from this focus source. the "large focus" and "micro focus" will still be operational.
  • Acción
    This action is a follow-up to RC-2014-RN-01035-1. Following from the software updated implemented under the original action Siemens are now replacing all potentially affected X-ray tube assemblies with a version in which the cause of the potential malfunction has been eliminated. This action has been closed-out on 11/08/2016.

Device

Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assembly
  • Modelo / Serial
    Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assemblyCatalogue/Lot numbers: X-ray tube assemblies 10144184 and 10145086 from a specific production lotARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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