Events

Retiro De Equipo (Recall) de Device Recall ARTISTE MV with Artiste Digital Linear Accelerators

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., Concord, CA.

¿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
    57704
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1422-2011
  • Fecha de inicio del evento
    2010-12-03
  • Fecha de publicación del evento
    2011-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97050
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    The firm become aware of a potential issue with artiste system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is over the patient.
  • Acción
    The firm, Siemens, issued a "Customer Information" letter on December 3, 2010 via mail to all its direct consignees/customers. The letter described the product, problem and actions taken by the firm to the customer. Siemens arranged for an inspection of their customers systems to make sure the safety mechanism is fully functional. Siemens instructed the customers to include the Customer Information letter in their ARTISTE System Owner manual chapter 'Safety Advisory Letters' . If you any questions, please call 925-246-8407.

Device

Device Recall ARTISTE MV with Artiste Digital Linear Accelerators
  • Modelo / Serial
    Serial No. 5647 - 5718  (Specifically 5647,5651,5652,5660,5657, 5664,  5654,5686,5687,5688,5689, 5606,  5690,5700,5701,5699,5704,5705,5707,5708,  5714, 5716, and 5718)
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789; || Intended use: To deliver x-ray radiation for therapeutic treatment of cancer. || Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA; and Siemens Medical Solutions AG, Roentgenstrasse, Kemnath, Germany, and Siemens Medical Solutions AG, Henkestrasse, Erlangen, Germany
  • Manufacturer
    Siemens Medical Solutions USA, Inc., Concord, CA

Manufacturer

Siemens Medical Solutions USA, Inc., Concord, CA
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc., Concord, CA, 4040 Nelson Ave, Concord CA 94520-1200
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA