Events

Retiro De Equipo (Recall) de Device Recall SEQUENCER for 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
    55087
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1029-2011
  • Fecha de inicio del evento
    2010-03-10
  • Fecha de publicación del evento
    2011-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90908
  • 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 Linear Accelerator - Product Code IYE
  • Causa
    Computer interface is defected. computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.
  • Acción
    A User Notice was sent by the firm to its consignees. It identified the affected product and the reason for the recall. It also discussed the clinical impact and interim mitigations. The firm states in the letter that a fix for the problem and been developed and is available. Customers are to contact IMPAC Support for the patch to the SL75-5 interface. If customers have questions, concerns, or requests, they can email support@impac.com or one of the numbers listed in the letter for the applicable country. The letter should be distributed to all users affected by the issue at the customer's organization.

Device

Device Recall SEQUENCER for Mosaiq
  • Modelo / Serial
    Sequencer for MOSAIQ versions: 1.20, 1.30 ; 1.50 , 1.60 and 2.00, interfacing to an Elekta SL 75-5 Linacs.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Canada, Germany, and France.
  • Descripción del producto
    SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. || Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control.
  • 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