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Recall Observatory FDA recall evidence

Device product

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.

Z-2665-2014

August 19, 2014

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 69129
Status
Terminated
Classification
Class II
Quantity
858
Official record key
device-enforcement:Z-2665-2014

Official wording

Reason: 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.

Code information: Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software version 14. The issue