Events

Retiro De Equipo (Recall) de ARTISTE, ONCOR and PRIMUS Linear Accelerator systems

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
    61545
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1486-2012
  • Fecha de inicio del evento
    2012-04-03
  • Fecha de publicación del evento
    2012-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108392
  • 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 has received reports where a dropping down of the 550 txt" treatment table was observed while the table was being moved downwards during operation by means of the hand control.
  • Acción
    Siemens sent Customer Information letters to all affected customers beginning April 3, 2012 via Siemens Field Service Engineers. The letter identified the affected product, what is the issue and what has Siemens done to address this issue. The letter included an Update Instructions TH006/12/S - TxT Table Software Update VD00A. SIEMENS has arranged for a modification of the affected system. A SIEMENS Service Representative will ensure that the new software version VD00A is installed on affected system. The letter instructs customer to please include this Customer Information in their Digital Linear Accelerator System Owner Manual chapter Safety Advisory Letters where it should remain.

Device

ARTISTE, ONCOR and PRIMUS Linear Accelerator systems
  • Modelo / Serial
    System IVK no. Component Component IVK Ser #  ARTISTE MV system 8139789 550 TxT table 7346534 d1894 ONCOR Expression 7360717 550 TxT table 7346534 d1894 ONCOR Impression 5857912 550 TxT table 7346534 d1894 Plus ONCOR Impression 5857920 550 TxT table 7346534 d1894 ONCOR Avant Garde 5863472 550 TxT table 7346534 d1894 PRIMUS HI 4504200 550 TxT table 7346534 d1894 PRIMUS Mid-Energy 1940035 550 TxT table 7346534 d1894
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including P.R and the countries of: Africa, Angola, Argentina, Australia, Austria, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Russian Federation, Saudi Arabia, Serbia, South Thailand, Sri Lanka, Spain, Switzerland, Trinidad, Tobago, Turkey, Ukraine and United Kingdom, .
  • Descripción del producto
    Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table. || Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS || Roentgenstrasse 19-21 || Kemnath, GERMANY 95478. || Product Usage: || The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is 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