Siemens Syngo.plaza PACS Software Recall for Issue Resolution
Siemens Medical Solutions is recalling 62 Syngo.plaza PACS systems to install a software update that resolves several 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, and the source text describes a software update to resolve issues without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary action.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 62 units of the Syngo.plaza picture archiving and communications system (PACS). The recall involves specific model numbers 10863171, 10863172, and 10863173, along with a list of specific serial numbers. These systems were distributed throughout the United States.
The recall is being conducted to install a software update intended for improvements and to resolve several issues. The source text does not specify the nature of the issues or report any associated injuries, illnesses, or deaths.
Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. to arrange for the installation of the software update.
The recalled product
- Product
- Syngo.plaza, picture archiving and communications system.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 62
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 (2)
- Model Number: 10863171
- 10863172
Distribution
Distribution scope not specified by the agency.
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