Events

Retiro De Equipo (Recall) de Luminos dRF and Uroskop Omnia systems with Software Version VD10

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-01083-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-25
  • 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-01083-1
  • 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 identified the following potential malfunctions:1. during a rad (radiography) examination with automatic exposure control, a highly unlikely malfunction can result in radiation continuing longer than required. this malfunction happens when the generator stops the tube power too late and therefore too much dose is applied during an acquisition. this may also result in an overexposed image that is not of diagnostic quality, so that the examination needs to be repeated. (note: this issue also affects software versions vc10 and vb10. devices running this software are being corrected under recall rc-2013-rn-01037-1.)2. when selecting a tomo ogp, in some cases the luminos drf system shows a message "wait for flc" and this state does not change on its own.3. radiation is not activated and therefore an exposure is performed without radiation.
  • Acción
    It is not possible for the user to prevent this malfunction. The exposure time with the use of automatic exposure control is limited to 500ms, which is the maximum time that unwanted radiation will continue. The exposure can be interrupted by the user at anytime by releasing the exposure button. Siemens has implemented a field modification that will resolve the issues. The Australian roll out of this field modification is planned for completion in Q4 2013/Q1 2014.

Device

Luminos dRF and Uroskop Omnia systems with Software Version VD10
  • Modelo / Serial
    Luminos dRF and Uroskop Omnia systems with Software Version VD10Catalogue Numbers:10094200, 10094910Siemens Reference Numbers: XP031/13/SARTG Number: 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

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