Events

Retiro De Equipo (Recall) de EasyLink Data Management System

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 Siemens Healthcare Diagnostics, 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
    71204
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1942-2015
  • Fecha de inicio del evento
    2015-04-29
  • Fecha de publicación del evento
    2015-06-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136533
  • 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
    System limitations and software issues related to the following features: custom reference ranges, user-initiated sample and result actions, auto-verification and quality control rules, and sample reports.
  • Acción
    Siemens sent an Urgent Field Safety Notice (UMDC # ISW-15-01.A.US) on May 5, 2015 to all affected customers. The letter instructed customers to follow specific work around instructions, review this letter with their Medical Director, complete and return the Field Correction Effectiveness Check attached to this letter within 30 days, retain the letter with laboratory records, and forward it to those who may have received this product. For questions regarding this recall call 800-441-9250.

Device

EasyLink Data Management System
  • Modelo / Serial
    Catalog Numbers: 10444799, 10444800, 10487219
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Canada, Switzerland, Germany, Denmark, Spain, France, Hong Kong, Italy, Japan, Korea, Malaysia, Netherlands, Norway, New Zealand, Philippines, Portugal, Saudi-Arabia, Slovenia, and Taiwan.
  • Descripción del producto
    EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA