| Class 2 Device Recall Siemens CentraLink Data Management System | |
Date Initiated by Firm | August 19, 2014 |
Date Posted | September 18, 2014 |
Recall Status1 |
Terminated 3 on May 12, 2017 |
Recall Number | Z-2665-2014 |
Recall Event ID |
69129 |
Product Classification |
unknown device name - Product Code N/A
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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. |
Code Information |
Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr Ms 514 PO BOX 6101 Newark DE 19702-2466
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For Additional Information Contact | Customer Support 800-441-9250 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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