Siemens Medical Solutions Recalls Syngo.plaza VB10A Picture Archiving Systems
Siemens Medical Solutions USA, Inc. is recalling 47 Syngo.plaza VB10A Picture Archiving and Communication Systems to eliminate several software issues.
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 injuries, illnesses, or specific high-risk hazards, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 47 units of the Syngo.plaza VB10A Picture Archiving and Communication System. The recall is being conducted to eliminate several software issues identified in the product.
The affected systems were distributed nationwide. The recall notice lists specific serial numbers for the 47 units involved in this action.
The source text does not specify the exact nature of the software issues, the potential impact on patients or operators, or specific instructions for consumers or healthcare facilities beyond the general purpose of the software upgrade.
The recalled product
- Product
- Syngo.plaza VB10A, Picture Archiving and Communication System
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 47
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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