Siemens Syngo Imaging XS PACS Recall for Incorrect Print Sizes
Siemens is recalling 42 units of Syngo Imaging XS software because printouts may be in incorrect anatomical size when using unsupported printers.
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 hazard involves incorrect print sizes which is a functional defect without reported injuries or hospitalizations, fitting the Moderate criteria for low-risk issues.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 42 units of the Syngo Imaging XS Picture Archiving and Communication System (PACS) software, version VB10C. The recall affects the Syngo Workflow SLR System.
The recall is due to a defect where printouts may be printed in incorrect anatomical size. This issue occurs when using the syngo Imaging XS filming application in conjunction with a printer that has not been released for anatomical print usage, specifically due to an invalid combination of the printer and the syngo Imaging XS printer configuration file.
The affected units were distributed to facilities in Alabama, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, and Wisconsin. Users should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the printer configuration issue.
The recalled product
- Product
- Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 42
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 10558586 Software version VB10C
Distribution
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