Siemens Syngo.Via Software Recall for Report Functionality Defect
Siemens Medical Solutions is recalling Syngo.Via VB20A software because corrected report values are not saved or transmitted, causing the system to use original values.
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, but the source text describes a software functionality defect without reporting any injuries, illnesses, or deaths. Per the rubric, this falls under moderate risk as it is a defect without reported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Syngo.Via VB20A model 1049610 software. The recall is due to a functionality defect in the report sections "Findings Information" and "Summary of Measured Findings."
The issue prevents corrected values modified in the report from being saved, printed, or sent to the information system. Consequently, the system continues to use the original values rather than the corrected ones.
The recall is distributed nationwide. Consumers and healthcare providers should contact Siemens Medical Solutions for further instructions regarding the software update or replacement.
The recalled product
- Product
- Syngo.Via VB20A model 1049610
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
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)
- All
Distribution
Distributed nationwide across the United States.
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