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Terminated

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.

FDA Recall Z-2665-2014 · Posted 2014-09-18

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeN/A
Date Initiated2014-08-19
Date Terminated2017-05-12
Product Quantity858

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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