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
    58186
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2662-2011
  • Fecha de inicio del evento
    2011-03-10
  • Fecha de publicación del evento
    2011-06-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98621
  • 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
    There's a problem in the database conversion program that is used when upgrading from the multi-acc¿s to mosaiq or from one version of mosaiq to another. if the gantry start angle is incorrect prior to pressing beam-on, the patient will be mistreated.
  • Acción
    The firm, Elekta, sent a "USER NOTICE" to its customers with an attached confirmation of receipt form. The notice describes the product, problem and actions to be taken. The customers were instructed to follow the Interim mitigation instructions noted in the notice -verify the Arc start angle of the Simple ARC with MLC treatment field definition prior to delivery and if the customer identifes a field with an errant gantry start angle, to cease using that plan immediately and consult with the original plan for that field and make the correction to the gantry start angle. In addition, the customers were instructed to complete and return the Confirmation of Receipt via fax to: North America and Asia at 702-992-5002 or Europe and Africa +44 (0)1293 654401, Attn: Elekta OIS Su[pport and/or scan and email to: support@impact.com, europe.support@impact.com or by mail; and distribute this notice to any all users of IMPAC software at their organization who are potentially affected by this issue. For questions or requests for upgrade, email support@impac.com (North America/Asia) or europe.support@impac.com (Europe) or call USA 1-800-488-4672.

Device

Device Recall Elekta Impac Software Sequencer
  • Modelo / Serial
    MOSAIQ 1.30, 1.60, 2.00, 2.10, and 2.20; including all service packs.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and country of Canada.
  • Descripción del producto
    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ || 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. It gives the capability to notify users of actions that need to take place prior to treatment, to display reference images for set up purposes and to auto setup the machine to predefined settings.
  • 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