Events

Retiro De Equipo (Recall) de Elekta Synergy XVI R4.5

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 Elekta, 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
    57960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1723-2011
  • Fecha de inicio del evento
    2010-10-25
  • Fecha de publicación del evento
    2011-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97838
  • 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
    Medical charged-particle radiation therapy system. - Product Code IYE
  • Causa
    If another patient is selected on the imaging system (xvi) release 4.5) during the transmission of end of treatment data from desktop pro r7.01 to r&v; system, the xvi information is prioritized and the end of treatment data is never received by the r&v; system.
  • Acción
    Important Notice A341 titled "Mandatory Upgrade Desktop Pro R7.01 Service Pack and Cancelled Notices" dated January 26, 2011, is in distribution to all affected customers. Field Change Order 20000501011, "Service Pack 2 upgrade to Desktop Pro R7.01 Service Pack 1", dated October 25, 2010 will be utilized by Elekta Service personnel to upgrade the Desktop Pro to include Service Pack 2. The Important Notice letter instructed customers to file the letter in the Important Notice section of the appropriate User Manual. Before doing so, users are to ensure that Desktop Pro R7.01 SP2 is installed on their treatment control system. If it is not installed, customers are to contact their local Elekta representative. Once the installation of Service Pack 2 has taken place, the notices listed in Table 1 of the letter will no longer be applicable and should be removed from the User Manual. Customers should direct their questions to their local Elekta representative.

Device

Elekta Synergy XVI R4.5
  • Modelo / Serial
    Serial Numbers 152019, 152117, 151566, 152271, 151942, 152116, 151141, 151885, 152211, 152214, 152158, 151628, and 152207.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Class 2 Recall -- Nationwide Distribution -- Including CA, MI, MO, ND, OH, OR, RI, VT, and WI.
  • Descripción del producto
    Elekta Synergy XVI R4.5 || Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Dirección del fabricante
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA