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
    61580
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1493-2012
  • Fecha de inicio del evento
    2012-04-03
  • Fecha de publicación del evento
    2012-05-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108483
  • 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 (issue 1). additionally, there may be a potential for collision if the operator does not ensure clearance of the extended flat panel positioner for all gantry rotation angles (issue 2).
  • Acción
    Siemens sent a Safety Advisory Notice with Update to all affected customers. The notice informed the customers of the risk of pressing the Motion Stop button repeatedly during treatment. Work Steps were provided for customers to follow.

Device

ARTISTE or ONCOR Linear Accelerators in combination with 160MLC
  • Modelo / Serial
    Product Model with Part Number: ARTISTE MV System, 8139789; ONCOR Avant Garde, 5863472; ONCOR Impression, 5857920; ONCOR Impression, Plus 5857912; ONCOR Expression, 7360204; ONCOR Expression, 7360717
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including the states of 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. || Product Model with Part Number: || ARTISTE MV System, 8139789; || ONCOR Avant Garde, 5863472; || ONCOR Impression, 5857920; || ONCOR Impression, Plus 5857912; || ONCOR Expression, 7360204; || ONCOR Expression, 7360717. || 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