Retiro De Equipo (Recall) de SEQUENCER

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 Impac Medical Systems 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Varian reported a problem related to certain collimator rotation values which are incorrect on truebeam compared to planned values in mosaiq.
  • Acción
    " Impac Medical Systems Inc., sent an USER NOTICE letter to all affected consignees on September 20, 2011. The letters identified the source characterization error, clinical impact, and final resolution. The letter states that Elekta Support will follow up with each consignee and remotely correct the source characterization. Customers were instructed to sign, date and return the attached Confirmation of Receipt Form by one of the three ways indicated. The letter instructs consignees to distribute this notice to any and all users of IMPAC software that may potentially be affected by the issue. For questions, concerns, and requests for upgrade, email or call. The letter provided consignees with a complete list of contact information..


  • Modelo / Serial
    All sites with the configuration of the 4D IEC 1217 source file used for the Varian TrueBEam treatment machine.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution (USA) - including the states of: AZ, CA, FL, NJ, NY, NV, TX, VA and WA.
  • Descripción del producto
    Impac Medical Systems Sequencer || Product Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability to notify the user of actions that need to take place prior to treatment, to display reference images for set up purposed and to auto setup the machine to predefined settings. The actual settings are read from the treatment machine, via the machines communication interface, and compared to predefined values. if a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate points during the treatment, the actual delivered values are recorded to provide treatment tracking.
  • Manufacturer


  • Dirección del fabricante
    Impac Medical Systems Inc, 100 Mathilda Pl Fl 5th, Sunnyvale CA 94086-6076
  • Empresa matriz del fabricante (2017)
  • Source