Retiro De Equipo (Recall) de Siemens User Defined Method Flex Assignment/Dimension Vista 500 Dimension Vista 1500 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    When utilizing the routine inventory screen to enter a user defined method (empty) flex the system may assign the user defined method flex to a different flex that is currently in inventory on the system, and then use the incorrect flex cartridge to process the user defined method.
  • Acción
    Siemens sent a Urgent Medical Device Correction letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please use the following actions if using Vista SW Versions 3.5.1 and below to prevent the issue from occurring: 1. When assigning a User Defined (EMPTY) Flex, use the Advanced Inventory Screen per the Operators Guide. 2. Verify that EMPTY Flex is no longer listed in the inventory before proceeding with any testing. 3. If the EMPTY Flex is still listed in the inventory, contact your Siemens Customer Care Center - Technical Solutions for assistance. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Discuss the content of this letter with your Medical Director. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens technical support representative.


  • Modelo / Serial
    Material numbers 10284473, 10488224, 10444801, and 10444802.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    USA (nationwide) Distribution including Puerto Rico.
  • Descripción del producto
    User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower || User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
  • Manufacturer


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