Events

Retiro De Equipo (Recall) de Device Recall 550 TxT Treatment Tables which are used in PRIMUS, ONCOR, ARTISTE Linac 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
    67126
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0787-2014
  • Fecha de inicio del evento
    2013-12-05
  • Fecha de publicación del evento
    2014-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124745
  • 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
    Couch, radiation therapy, powered - Product Code JAI
  • Causa
    Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 txt treatment table. combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the txt" treatment table has been damaged due to contacting a moving part. the resulting short-circuit cau.
  • Acción
    The firm, Siemens, sent a "Medical Device Correction" letter to affected users/customers starting on December 5, 2013 via Federal express. The letter described the product, problem and actions to be taken. Siemens has arranged for modification of the affected 500 TxT Treatment Table. A service representative will modify the mounts of the TT-A, TT-D, TT-M, or TT-s table tops ( Pleases note that this modification only applies to the Siemens provided table tops TT-A, TT-D, TT-M, and TT-S.). In addition, the Siemens service representative will modify the cable routing inside of the patient table base. The customers were instructed to include this Field Safety Notice in your Digital Linear Accelerator System Owner manual chapter 'Safety Advisory Letters' where it should remain. If you have any questions, please contact the Senior Manager, Regulatory Affairs at 1-925-293-5442 or email: christine.dunbar@siemens.com.

Device

Device Recall 550 TxT Treatment Tables which are used in PRIMUS, ONCOR, ARTISTE Linac systems
  • Modelo / Serial
    550 TxT table - part number 07346534.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and internationally to: Canada, Italy, P.R. China, Argentina, Pakistan, South Africa, Egypt, Iran, Vietnam, Indonesia, Brazil, Hungary, Bulgaria, India, Spain, Switzerland, Trinidad, Tobago, Italy, Algeria, Croatia, Turkey, Japan, Germany, Portugal, Poland, France, Sri Lanka, Russian Federation, France, Lebanon, Slovakia, Ukraine, Pakistan, and Korean Republic.
  • Descripción del producto
    PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. || TT-A, TT-D, TT-M or TT-S Table tops. || Manufactured by: || SIEMENS AG, MEDICAL SOLUTIONS || Roentgenstrasse 19-21 || Kemnath, GERMANY 95478 || 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, 757 Arnold Dr Ste A, Martinez CA 94553-3615
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA