Events

Retiro De Equipo (Recall) de LX125 Swivel Collimator, Model D800

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 Summit Industries 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
    38512
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1216-2007
  • Fecha de inicio del evento
    2007-08-10
  • Fecha de publicación del evento
    2007-08-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53880
  • 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
    Radiographic Collimator - Product Code IZX
  • Causa
    The d800 swivel collimator may come loose from the tubestand and fall onto the x-ray table.
  • Acción
    The affected dealers were notified of the field correction recall by letter dated 8/3/07, informing them of the problem with the stripped screws and requesting that they notify their affected end user locations. The end user notification letters inform them of the problem and state that the dealer will be contacting them soon to arrange a time to visit the end user location and conduct the rework on the collimator, which should take less than 30 minutes. In the mean time the end user was instructed to examine their swivel collimator for looseness. If it is found to be loose, the end user was instructed to take the unit out of service and call the dealer.

Device

LX125 Swivel Collimator, Model D800
  • Modelo / Serial
    Model D800, serial numbers NA578-1092 to NE785-0201, all swivel units manufactured between 11/14/1992 and 02/13/2001
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Australia, Cambodia, Canada, Chile, Colombia, Dominican Republic, Ecuador, France, Germany, Haiti, Mexico, Nicaragua, Singapore, and South Africa.
  • Descripción del producto
    LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
  • Manufacturer
    Summit Industries Inc.

Manufacturer

Summit Industries Inc.
  • Dirección del fabricante
    Summit Industries Inc., 2901 W Lawrence Ave, Chicago IL 60625-3621
  • Source
    USFDA