Events

Retiro De Equipo (Recall) de Artis systems with large display module

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-2015-RN-01109-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-23
  • 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-01109-1
  • 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 improper soldering in limited components of a specific production lot of large display bypass module, a loss of video signal could potentially occur (will not show any image). radiation can still be applied without image, which could result in dose to the patient without clinical benefit. the error has not been observed in the field.
  • Acción
    Siemens will be replacing any potentially affected units with unaffected stock. This action has been closed-out on 24/08/2016.

Device

Artis systems with large display module
  • Modelo / Serial
    Artis systems with large display moduleSiemens Material Numbers: 10094135, 10094137, 10094141, 10094142, 10280959, 10848280, 10848281, 10848282, 10848283, 10848354 and 10848355ARTG Number: 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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