BEUDAMED
    FDA Recall 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.

    Recall: Z-2665-2014 · Initiated August 19, 2014

    Recall

    Recall Number
    Z-2665-2014
    Event Number
    69129
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 19, 2014
    Posted
    September 18, 2014
    Terminated
    May 12, 2017
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    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.

    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.

    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.

    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.

    Quantity

    858