Siemens Syngo.via Software Recall for Diagnostic Inconsistencies
Siemens Medical Solutions is recalling 30 Syngo.via systems with software version VB20A to resolve bugs and inconsistent diagnoses.
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 and addresses software bugs causing inconsistent diagnoses. No specific injuries, deaths, or hospitalizations are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 30 Syngo.via systems equipped with software version VB20A. The recall addresses various bugs and inconsistent diagnoses associated with the current software version.
The affected systems were distributed nationwide. A software update was released on August 22, 2017, which resolves these issues. Installing this update and upgrading the system to software version VB20A_HF02 will correct the identified problems.
Healthcare facilities should contact Siemens Medical Solutions to obtain the software update and perform the necessary installation to ensure accurate diagnostic performance.
The recalled product
- Product
- Syngo.via systems with SW VB20A
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 30
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 (1)
- 10496180
Distribution
Distributed nationwide across the United States.
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