Siemens syngo Lab Data Manager System Recalled for Software Issues
Siemens Healthcare Diagnostics is recalling 449 syngo Lab Data Manager systems due to software issues. The recall covers systems distributed in the US and nine other countries.
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, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or significant injuries are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is voluntarily recalling 449 syngo Lab Data Manager systems. The syngo Lab Data Manager is a clinical system that assists medical laboratory professionals with pre-analytic and post-analytic functions, working in conjunction with multiple instruments, laboratory information systems, and the Siemens Healthcare Diagnostics Data Center.
The recall was initiated due to software issues. The affected systems were distributed worldwide, including the United States, Japan, Germany, Belgium, France, Italy, Slovakia, the Bahamas, the United Kingdom, and Mexico. The recall was initiated on August 26, 2015, and was terminated on March 24, 2020.
The FDA classified this recall as Class II, which means the use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote. The recall was initiated by the firm and notified via letter.
The recalled product
- Product
- syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 449
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 (3)
- Catalog Numbers: 10638933
- 10624077
- 10804573 510K Exempt
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- HighSiemens syngo Lab Data Manager Recall for Quality Control Defect
FDA (Devices) · 2012-09-12
- HighSiemens syngo Lab Data Manager Software Recall for Auto-verification Failures
FDA (Devices) · 2013-12-11
- HighSiemens syngo Lab Data Manager Software Recall for Configuration Errors
FDA (Devices) · 2014-07-09
- HighSiemens syngo Lab Data Manager Recall for Incorrect Coagulation Results
FDA (Devices) · 2012-08-15
- ModerateSiemens EasyLink Data Management System Recalled for Software Limitations
FDA (Devices) · 2015-07-08
- ModerateSiemens Syngo.plaza PACS Systems Recalled for Software Update Issues
FDA (Devices) · 2017-03-29