Events

Retiro De Equipo (Recall) de Artis Q and Artis Q zen systems (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-00782-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-11
  • 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-00782-1
  • 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 i identified the following issues with the artis q and artis q zen systems:1. in certain circumstances the release of radiation is blocked in connection with an error with the large display, for example, where an image cannot be displayed on the large display. in rare cases the system misinterprets the status of the large display and blocks the release of radiation.2. in the case of installations configured with a hospital emergency power supply for the entire system, radiation release may be blocked due to a software error, because a non-existent emergency power situation is detected by mistake.3. the coupling of failures caused by an electronic control element might lead to a radiation abort.
  • Acción
    Siemens is providing a software patch to correct this issue. The software limits the blockage of radiation release to three seconds and the screen in the control room displays the message "No Xray, try again". After the next attempt, radiation can then be released without restriction. The software modification also prevents misinterpretation of the emergency power supply issue. An additional hardware signal supression component will be fitted to mitigate electronic control element failure. This action has been closed-out on 01/03/2016.

Device

Artis Q and Artis Q zen systems (Fluoroscopic X-ray systems)
  • Modelo / Serial
    Artis Q and Artis Q zen systems (Fluoroscopic X-ray systems)Multiple material numbers with software VD10D and Large DisplayARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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