Events

Retiro De Equipo (Recall) de Summit Industries Floor Mounted Tubestand

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
    69631
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0468-2015
  • Fecha de inicio del evento
    2014-10-28
  • Fecha de publicación del evento
    2014-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131205
  • 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
    Tube mount, x-ray, diagnostic - Product Code IYB
  • Causa
    The welds on j700 tube stands may be insufficient resulting in tube stand breakage, damage to the x-ray machine, and/or patient or healthcare provider injury.
  • Acción
    Summit Industries sent an Urgent Medical Device Recall letter dated October 27, 2014, to all direct accounts (distributors). The letters included instructions for distributors to: 1) make every effort to locate the affected devices; 2) replace and return the defective parts; 3) contact the end user for any defective device(s) that were installed and determine if the affected device(s) is/are in service; 4) if the device(s) is/are still in service, deliver a copy of the "End User Letter", immobilize the tube arm, and place the REMOVE FROM SERVICE sticker on the device; 5) complete and return the attached questionnaire for a no-charge purchase order for the necessary replacement parts; and, 5) inform the end user that new replacement pats will be installed as soon as possible. Distributors with questions can contact Summit Industries at 800-729-9729 (Monday - Friday, 7:00 AM - 3:45 PM CST). The Urgent Medical Device Recall letter dated October 27, 2014, to end users advised them of the recall and the steps that Summit Industries and their distributor would be taking to correct the issue.

Device

Summit Industries Floor Mounted Tubestand
  • Modelo / Serial
    Model Numbers: J700-01, J700-02, J700-03, J700-04
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of: AZ, CO, IL, KY, LA, NE, NY, OH, PA, TN, TX, VA, WA and WV.
  • Descripción del producto
    The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. The product consists of a vertical column (with counterbalanced vertical carriage, counterweight and pulley system), horizontal floor car and a floor mounted track to ride on.
  • Manufacturer
    Summit Industries Inc.

Manufacturer

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