Events

Retiro De Equipo (Recall) de Device Recall EasyLink Informatics 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
    62448
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2172-2012
  • Fecha de inicio del evento
    2012-06-07
  • Fecha de publicación del evento
    2012-08-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110694
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • Causa
    There is a potential for the easylink system to display and transmit to the laboratory information system networks an incorrect result following the easylink systems application of the configured result number format. the problem is encountered when the result number format configured on the sysmex ca-7000 or ca-1500 coagulation analyzer does not match the easylink system settings on the following.
  • Acción
    The firm initiated this recall on June 7, 2012 by issuing an "Urgent Field Safety Notice" to all customers who are known to have the EasyLink system and who also own and operate Sysmex CA-1500 and CA-7000 instruments. The Notice described the problem and provided recommended actions. Customers can contact 800-441-9250 for questions.

Device

Device Recall EasyLink Informatics System
  • Modelo / Serial
    Version 5.0 and Version 5.0 Service Pack 1 through 4
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution, including the countries of Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Switzerland and the United States, with nationwide distribution. Center Recall Depth is Retail.
  • Descripción del producto
    EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA