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 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-00818-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-28
  • 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-00818-1
  • 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 have received reports that under certain circumstances, when starting the system up or reconnecting the c-arm cable to the main unit, the error 5000/243 “no x-ray - fd re-initialises” may occur. the error refers to a potential hardware malfunction of the cios alpha c-arm x-ray system that may occur when starting the system up or reconnecting the c-arm cable to the main unit. when this occurs, the system will become inoperable until the affected part is replaced.
  • Acción
    Siemens is planning to release a modification for the Cios Alpha mobile C-arm x-ray system that will resolve the above-mentioned potential malfunction. As soon as the modification is available, a Siemens service engineer will contact customers to schedule implementation of the modification for your system. Siemens is providing the following instructions to minimise the risk of this issue: · Ensure that the system is ready after the startup · Ensure that the error 5000/243 is not displayed, neither as message box nor in the FLC status bar (lower left side of the left monitor) · In general, avoid disconnecting and reconnecting the C-arm cable during or shortly before starting a procedure. This action has been closed-out on 31/08/2016.

Device

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

Manufacturer

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