Events

Retiro De Equipo (Recall) de Cios Alpha mobile C-arm x-ray system

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-00399-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-13
  • 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-00399-1
  • 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
    Under certain circumstances the following user actions may cause the system to freeze. ·when images were transferred from the left monitor to the right monitor (function a to b) during image acquisition (i.E. radiation on) or shortly before starting image acquisition·when acquisition of image was started while storing of scenes initiated by pressing the store button was still in progress·when scene replay was initiated either automatically or by pressing the “play” button (especially when pressing the “play” button more than once) while the storing of those scenes was still in progress·when image acquisition was initiated again before automatic replay of the last scene started·when finalized cd/dvds were used to store additional data·when radiation summary reports with more than 190 entries were being exported·when system restart was initiated when the error message “system blocked. turn system off/on” (error codes 215/80 and/or 208/80) was displayed.
  • Acción
    Siemens has provided a workaround whilst a system modification is being developed which is expected for July 2015. This action has been closed-out on 11/08/2016.

Device

Cios Alpha mobile C-arm x-ray system
  • Modelo / Serial
    Cios Alpha mobile C-arm x-ray systemCatalogue number: 10308191ARTG number: 102180
  • Manufacturer
    Siemens Ltd

Manufacturer

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