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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- 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
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