Events

Retiro De Equipo (Recall) de Device Recall MOSAIQ

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
    52903
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1027-2011
  • Fecha de inicio del evento
    2009-07-17
  • Fecha de publicación del evento
    2009-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84252
  • 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
    Potential for improper treatment. a software error may result in potential major underdosing to targeted areas from jaw blockage of the mlc aperture (jaw intrusion), and dosing to non-targeted areas from interstitial leaf leakage (jaw extrusion).
  • Acción
    Impac Medical Systems Inc sent an Important Safety Notice letter to all affected consginees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Impact Software support as soon as possible if they have the affected configurations identified in the letter. Customers were asked to complete the form included with the letter and and fax to: European customers: +44 1293 654401 American & rest of world customers 702-992-5002 or e-mail to support@impac.com Customers were asked to distribute the Safety Notice to any and all users of IMPAC software at their organization who are potentially affected by this issue. For questions e-mail support@impac.com or call European customers: 44 1293 654320 American & rest of world customers: 800-488-4672.

Device

Device Recall MOSAIQ
  • Modelo / Serial
    MOSAIQ version 1.30 (all builds), MOSAIQ version 1.40 (all builds), MOSAIQ version 1.50 (all builds), MOSAIQ version 1.60 (all builds, and MOSAIQ version 2.0 (all builds).
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, CA, CT, FL, GA, IA, IL, KY, MI, MN, MS, ND, NJ, OH, OR, PA,TN, TX, VA, WA, WI, and WV and the country of Canada.
  • Descripción del producto
    SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). Manufactured by IMPAC Medical Systems, Inc. Sunnyvale, CA. || The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment on a radiotherapy treatment machine. SEQUENCER provides the capability to notify the 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. Actual settings are read from the treatment machine, via the machine's communication interface, and compared to the predefined values. If a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate times during the treatment, the actual delivered values are recorded to provide treatment tracking. Treatments are initiated by the operator, via the machine control system, only after the user has verified that the treatment setup is correct. SEQUENCER does not bypass any checks put in place by the machine's control system.
  • 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