Retiro De Equipo (Recall) de Integrated Data Management System Version 7.1, 7.2 and 7.3;

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 International Technidyne Corporation.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Causa
    A tabulation error in the integrated data management systems (idms) data management software that results in incorrect electronic quality control (eqc) summary reports: the operator and the device performance summary reports. the idms software is not used for the clinical management of individual patients.
  • Acción
    ITC sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 10, 2010 to Distributors and First Consignee End Users identifying the affected product and affected summary reports, the reason for recall, and the actions to be taken by the distributors and customers. New Errata Instructions were enclosed with each letter and are to be put in the idms user guide for reference. The new instructions are to be followed when running reports for the ESV or TVT tests run by the Hemochron Response. The enclosed Customer Account Tracking Form is to be completed and returned to ITC indicating that the letter has been received and appropriate questions answered as to the use of the software system. Distributors are asked to check inventory for recalled product. If affected product is found, shipment should be stopped and placed on hold. Distributors should notify customers of the correction and provide them with a copy of the correction letter and updated instructions. This should be done by traceable mail. Distributors should return the account tracking form and return affected software disks for replacement. Questions should be directed to ITC Technical Support at 800-631-5945.


  • Modelo / Serial
    Product code 464100, Version numbers 7.1.0, 7.2.0 and 7.3.0.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA including the states of AL, AZ, CA, FL, GA, IL, KS, LA, MD, MI, NC, ND, NJ, NM, NY, OH, PA, TN , TX, UT, VA, WA, and WI, and the countries of Italy, Turkey, Canada, France, Belgium, Germany, UAE, and New Zealand.
  • Descripción del producto
    Integrated Data Management System - Version 7.1, 7.2 and 7.3; || ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854
  • Manufacturer


  • Dirección del fabricante
    International Technidyne Corporation, 23 Nevsky St, Edison NJ 08820-2425
  • Empresa matriz del fabricante (2017)
  • Source