Events

Retiro De Equipo (Recall) de Device Recall Dimension Vista Intelligent Lab 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
    71315
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2054-2015
  • Fecha de inicio del evento
    2015-05-21
  • Fecha de publicación del evento
    2015-07-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137300
  • 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
    Two software issues may occur in vista software version 3.6.1. issue #1: samples may stop processing without notification. issue #2: timing issue in vista 1500 may cause wrong reagent or no reagent delivery. this may lead to unflagged, unexpected low results and results flagged with assay errors.
  • Acción
    Siemens sent an Urgent Medical Device Correction letter dated May 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer: For the corresponding issues listed above, please perform the following: Issue 1: If you experience this situation, sample processing can be resumed using the step(s) below: Step 1: From the Operation Icon select PAUSE, then immediately return to the Operation Icon and select Cancel PAUSE. Sample aliquotting should immediately resume. Step 2: If sample processing does not resume after Step 1, wait until the instrument displays System Ready, then restart the system software per the Vista Operator Guide, Section 2, Controlled Shutdown-Restart procedure. Issue 2: To prevent the Reagent Servers from temporarily losing synchronization, Siemens recommends setting the Auto Dispose option to No for methods assigned to Reagent Server 2 (see instructions below). These empty or expired reagent cartridges will now remain on the instrument and require the operator to unload them. Please consult your Vista Operators Guide or method Instructions for Use when results with flags and/or errors occur. We apologize for the inconvenience this situation may cause. 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.

Device

Device Recall Dimension Vista Intelligent Lab System
  • Modelo / Serial
    Siemens Material Number (SMN): 10284473, 10488224, 10444801, 10444802
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Austria, Australia, Belgium, Canada, Denmark, France, Finland, Germany, Japan, Italy, New Zealand, Netherlands, Czech Republic, Portugal, Republic Korea, Norway, Spain, Switzerland, Slovakia, Saudi Arabia, Slovenia, and United Kingdom,
  • Descripción del producto
    Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
  • 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