Events

Retiro De Equipo (Recall) de Device Recall Elekta Impac Software 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
    Recall
  • ID del evento
    55712
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0159-2011
  • Fecha de inicio del evento
    2010-02-19
  • Fecha de publicación del evento
    2010-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91633
  • 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
    System, planning, radiation therapy treatment - Product Code MUJ
  • Causa
    Mistreatment-- the database conversion utility used during the upgrade errantly changes the start gantry angle to zero. any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.
  • Acción
    ELEKTA IMPAC SOFTWARE sent a USER NOTICE dated February 19, 2010, to all customers. The notice identified the product, the problem, and the action to be taken by the customers. Customers were urged to verify the start angle of the gantry against the treatment field definition prior to delivery. Review all treatment plans and charts with conformal arcs. If a treatment plan with an errant gantry start angle was identified, customers were to cease using that plan immediately. A workaround was to be re-imported into their current version of MOSAIQ. IMPAC Support was to follow-up with each site and execute a script to detect and correct all affected treatment plans. For questions, concerns, and requests for upgrade, customers were to email support@impac.com or call their support center.

Device

Device Recall Elekta Impac Software Sequencer
  • Modelo / Serial
    Sequencer for MOSAIQ 1.60W3 (including all service packs), 2.00T2 (inclusing all service packs), 2.10L5 (including all service packs) and 2.10M7 (including all service packs).
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Australia, Belgium, France, Germany, Hong Kong, Ireland, Israel, and Italy
  • Descripción del producto
    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. || The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine.
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

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