Events

Retiro De Equipo (Recall) de Artis systems running software version VC21B in conjunction with a Large Display

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-2013-RN-01350-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-20
  • 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-2013-RN-01350-1
  • 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
    If the system is not turned “off” manually at regular intervals an automatic reset of the large display controller can occur. during the reset the system switches for approximately 1-2 minutes into the “bypass fluoro” mode. during this time only the native fluoroscopic image is displayed.
  • Acción
    Siemens is advising operators of the Artis system to ensure that the system is manually turned off at regular intervals. A software update will be implemented to correct the problem.

Device

Artis systems running software version VC21B in conjunction with a Large Display
  • Modelo / Serial
    Artis systems running software version VC21B in conjunction with a Large DisplayARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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