Siemens syngo Imaging XS Software Recall for Miscalculation Defect
Siemens Medical Solutions is recalling 52 syngo Imaging XS systems due to potential miscalculation of grey scale values in specific image processing functions.
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 the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 52 units of the syngo Imaging XS radiological image processing system. The recall affects version VA70A or higher of the software. The units were distributed nationwide to facilities in California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Maryland, Minnesota, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Wisconsin.
The recall is due to a potential malfunction where the system may miscalculate grey scale values. This issue can occur when using the "Regions of Interest," "Pixel Lens," "Edge Enhancement," and "Histograms" functions. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software malfunction. The recall is classified as Class II by the FDA.
The recalled product
- Product
- syngo Imaging XS. Radiological image processing system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 52
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 10496279
Distribution
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