Siemens Syngo.plaza PACS Software Recall for Database Error
Siemens is recalling 74 Syngo.plaza PACS systems due to a software error that may create duplicate image references in the database.
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. The hazard is a software data integrity error (duplicate references) rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity involving minor errors or low-risk issues.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 74 units of the Syngo.plaza Picture Archiving and Communication System (PACS). The affected model numbers are 10863171, 10863172, and 10863173. The recall is due to a software error in previous versions where two references for the same image may exist in the database.
The affected systems were distributed in the United States to the states of Alabama, California, Connecticut, Florida, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, Texas, and Wisconsin. Specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the software error. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — PACS Software
- Affected units
- 74
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 (20)
- Serial Numbers: 100389
- 100198
- 100258
- 100259
- 100538
- 100133
- 100213
- 100214
- 100031
- 100484
- 100362
- 100233
- 100140
- 100141
- 100142
- 100143
- 100144
- 100416
- 100105
- 100106
Distribution
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