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.
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, 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 the
- 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.
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