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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2665-2014

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.

Publicado el 24 de septiembre de 2014 · Inicio del retiro: 19 de agosto de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Siemens Healthcare Diagnostics, Inc.
Distribuidor
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.
Lote
Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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