Siemens CentraLink Software Recall for Potential Patient Data Release Error
Siemens is recalling CentraLink Data Management System software versions 14.0.4, 14.0.5, and 14.0.8 because a disabled patient result may be released without proper review.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the potential release of patient data without review, which is a risk-of-harm product issue where specific injuries or illnesses have not been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 40 units of the CentraLink Data Management System software, specifically versions 14.0.4, 14.0.5, and 14.0.8. The software is a network solution provider and multi-system data manager used to consolidate data from laboratory instruments and automation systems. The affected units were distributed in Minnesota, New Jersey, and Nevada.
The recall is due to a software defect where, under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. This issue could occur when a disabled test in the CentraLink or Aptio system becomes enabled in the CentraLink system.
Healthcare facilities using the affected software versions should contact Siemens Healthcare Diagnostics for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 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. The CentraLink software consolidates data…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 40
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 (7)
- CentraLink" Data Management System V14.0.4
- V14.0.5 or V14.0.8 Catalog Numbers: 10810210
- 10811596
- 10814296
- 10814298
- 10814877
- 10815474.
Distribution
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