Retiro De Equipo (Recall) de Siemens RAD Flouro Uro

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Medical Solutions USA, Inc.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • Causa
    When using systems operating with software versions vd10a/g during a rad examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.
  • Acción
    Siemens sent an Field Safety Notice dated September 3, 2013, to all affected customers.The letter identified the product the problem and the action to be taken by the customer. Action to be taken: 1. 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 duration of radiation in this mode. The exposure can be interrupted by the user at anytime by releasing the exposure button. 2. There are two possibilities to solve this issue: a.) Switch off the system if the message "wait for FLC" in status bar does not disappear approximately. 30s after the OGP selection. The system gets ready after switching the system on and reselecting the Torno OGP. b.) Press Shift+F10. The pop up message has to be confirmed and you have to wait approximately. 40s until! the "i" icon in the status bar stops blinking. After that a RAD OGP has to be selected and then the Torno OGP. Thereafter, the system gets ready. 3. It is not possible for the user to prevent this malfunction The Center for Devices and Radiological Health (CDRH) understands that your Corrective Action Plan (CAP) will involve 59 units and consist of the following elements: 1. You have notified affected customers with Field Safety Notice XP032/13/S. 2. You have prepared a field modification of the Luminos dRF and Uroskop Omnia systems with software version VD10A/G. 3. Distribution of this field modification will began in September 2013 as Update Instruction XP015/13/S at no cost to the user. For further Customer Support call (610) 219-6300.


  • Modelo / Serial
    Model numbers 10094910 and 10094200 with software version VD10A/G.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada.
  • Descripción del producto
    Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G || Image intensified Fluoroscopic X-ray system
  • Manufacturer


  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
  • Source