The Recall Desk
ModerateFDA (Devices)·Z-2665-2014·Announced 2014-09-24

Siemens CentraLink Data Management System Software Recall for Timer Overflow

Siemens is recalling CentraLink Data Management System software version 14 due to a task scheduler issue that may stop command execution and result uploads.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software defect causing data processing delays and command execution failures, which is a significant operational risk but does not involve direct physical injury or high-risk biological pathogens.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 858 units of the CentraLink Data Management System, software version 14. The recall is due to a task scheduler issue related to an internal software timer that overflows after 24 days.

This issue may cause the software to stop executing commands, including the uploading of validated results to the Laboratory Information System (LIS). Automated rules triggered by task schedulers or user interface actions may also be affected. Because customer configurations vary, the specific consequences of discontinued command execution will differ by site.

The affected software was distributed worldwide, including the United States (nationwide), Puerto Rico, and numerous international countries. Siemens Healthcare Diagnostics, Inc. is the recalling firm.

The recalled product

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.
Affected units
858

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Catalog Numbers: 10810210
  • 10811596
  • 10814296
  • 10814298
  • 10814877
  • 10815474

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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