Events

Retiro De Equipo (Recall) de Siemens 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
    68965
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2561-2014
  • Fecha de inicio del evento
    2013-08-13
  • Fecha de publicación del evento
    2014-09-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129137
  • 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
    May not perform as intended under certain conditions, causing the release of results to the laboratory information system (lis) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the lis.
  • Acción
    Siemens issued an Urgent Medical Device Correction (UMDC) letter on August 13, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review this letter in its entirety and ensure that all operators understand the information presented. The issues described are specific to the features listed in the letter.. If the laboratory is not using a particular feature, then they are not affected by the issues described for that feature. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Siemens EasyLink Data Management System
  • Modelo / Serial
    EasyLink Informatics System V4.0/V5 Siemens Material Number (SMN) 10444799, 10444800, 10487219
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Siemens EasyLink Informatics System V4.0/V5 || Siemens, Material Number (SMN) || 10444799, 10444800, 10487219 || 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