Events

Retiro De Equipo (Recall) de ARTISTE or ONCOR Linear Accelerators in combination with 160MLC

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
    Recall
  • ID del evento
    58637
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2404-2011
  • Fecha de inicio del evento
    2011-04-15
  • Fecha de publicación del evento
    2011-06-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99754
  • 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
    Siemens became aware of a potential safety risk related to the behavior of the 160 mlc when using the "motion stop" button followed by "reset" several times during the treatment of one beam or one segment.
  • Acción
    Siemens sent a Consumer Safety Advisory and Urgent Medical Device Correction letter to all affected customers beginning on April 15, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Updated instructions for using the Motion Stop button with the 160-MLC were provided with the letter. Customers were requested to use the Motion Stop button and the corresponding reset procedure only when required. In the unlikely event that the Motion Stop button needs to be used repeatedly during treatment of the same beam or segment, customers were advised to perform an "in session resumption of the beam by selecting 'abort' at the syngo RT Therapist and then re-selecting the beam again for the remaining delivery. In this case, the beam will be re-loaded with the originally prescribed leaf positions. Please consider the already delivered dose for resumption. Customers were asked to include the Customer Advisory Notice in their LINAC System Owner Manual in chapter 'Safety Advisory Letters' where it should remain until the measures defined above were performed. Customers were asked to inform all affected personnel immediately.

Device

ARTISTE or ONCOR Linear Accelerators in combination with 160MLC
  • Modelo / Serial
    Product Model Number ARTISTE MV System 8139789 ONCOR Avant Garde 5863472  ONCOR Impression 5857920 ONCOR Impression Plus 5857912 ONCOR Expression 7360204 and 7360717
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV.
  • Descripción del producto
    ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: || ARTISTE MV System; || ONCOR Avant Garde || ONCOR Impression || ONCOR Impression Plus || ONCOR Expression. || Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany; || Registered by Siemens Medical Solutions, Concord, CA. || ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA