Z-2665-2014Class II

Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network...

Name: Z-2665-2014 Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-08-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-08-19 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for... on 2014-08-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2665-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-19
Posted: 2014-09-18
Terminated: 2017-05-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: N/A
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 858
Distribution: 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.
Product codes and lots: Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2665-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2665-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-18

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)