Siemens syngo.plaza Radiological Image Processing System Recalled for Malfunction
Siemens is recalling two syngo.plaza radiological image processing systems due to a potential malfunction where images may fail to load without an error message.
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 malfunction that does not explicitly report injuries, hospitalizations, or structural defects, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling two units of the syngo.plaza radiological image processing system, model number 10592457. The recall is due to a potential malfunction identified in software version VA20C_HF01.
The issue affects datasets with distance measurements, where all images may fail to load in the Viewer without displaying an error message to the user. This could result in incomplete data being viewed or processed.
The affected units were distributed nationwide in the United States, including California, Florida, Georgia, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Washington, and Wisconsin. Users should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the software issue.
The recalled product
- Product
- Siemens syngo.plaza. Radiological image processing system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 2
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 10592457
Distribution
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