Events

Retiro De Equipo (Recall) de Device Recall Siemens CentraLink 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
    69129
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2665-2014
  • Fecha de inicio del evento
    2014-08-19
  • Fecha de publicación del evento
    2014-09-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129688
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    unknown device name - Product Code N/A
  • Causa
    Siemens healthcare diagnostics has identified a task scheduler issue with the centralink" data management system, software version 14. the issue may cause the software to stop executing commands, including uploading validated results to the lis. the issue is related to an internal software timer that overflows after 24 days. automated rules triggered by task schedulers or by actions in the centralink user interface may also be affected. as each customer configuration is unique, in addition to the delay in uploading of validated results, the specific consequences of discontinued command execution will vary.
  • Acción
    An Urgent Medical Device Correction (UMDC #10819364) letter was issued on August 19, 2014 to all affected customers. The letter instructed customers as follows: Siemens Healthcare Diagnostics is conducting a field correction for the CentraLink" Data Management System. To prevent the issue from occurring, log out of user sessions and restart the CentraLink services and translators as soon as it is convenient, then periodically restart going forward. Any restart frequency that occurs more often than every 24 days is acceptable and will prevent the issue from occurring. Refer to the Additional Information section for detailed instructions.

Device

Device Recall Siemens CentraLink Data Management System
  • Modelo / Serial
    Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474
  • Distribución
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Lebanon, Lithuania, Luxemburg, Malaysia, Mexico, Netherland, New Zealand Norway, Pakistan, Portugal, Peru, Qatar, Russia, Saudi Arabia, Singapore Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand United Arab Emirates, United Kingdom, Uruguay, Zambia.
  • Descripción del producto
    Siemens CentraLink Data Management System, software version 14. || The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
  • 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