Siemens Syngo.via Software Recall for Incorrect Report Data
Siemens is recalling Syngo.via software because it fails to save corrected report values, potentially sending outdated information to physicians.
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 does not report any hospitalizations, injuries, or deaths. The hazard is a data integrity issue that could lead to outdated information being sent to physicians, fitting the criteria for a moderate severity recall without reported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 236 units of Syngo.via Medical Device Software, a picture archiving and communications system. The recall addresses a software functionality issue in the 'Findings Information' and 'Summary of Measured Findings' report sections.
The system is not performing properly because it uses original values instead of displaying and saving corrected or modified values. This defect means that outdated information could be sent to the referring physician when creating the formal report in the reporting system.
The device is software only, and no products are distributed to wholesale dealers, distributors, or retailers. Users should be aware that the software may not reflect the most recent corrections in generated reports.
The recalled product
- Product
- Syngo.via. Medical Device Software. Picture archiving and communications system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Affected units
- 236
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)
- Model Number 10496180
Distribution
Distribution scope not specified by the agency.
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