Company: Siemens Healthcare Diagnostics, Inc..
Date of Enforcement Report: 9/24/2014
Class lI:
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.
Recall Number Z-2665-2014
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.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE on 8/19/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
858
DISTRIBUTION
Nationwide and Internationally
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