Siemens syngo Dynamics Information System Recall for Data Loss Risk
Siemens is recalling syngo Dynamics Information System versions 9.5 and VA10A because images may not be saved when specific modality settings are used.
What this means for you
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, which typically corresponds to a moderate severity score. The hazard involves potential data loss (images not saving) rather than direct physical injury or death, and no illnesses or injuries are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The recall involves nine units distributed in the United States, specifically in Pennsylvania, Ohio, Utah, California, New York, Missouri, and Texas. The affected model numbers are 10091637 and 10091805, with specific serial numbers listed in the agency record.
The recall was initiated due to a potential issue with the sDIS matching rules. When a modality device is configured to end a study at association close, images or DICOM SR objects sent to the syngo Dynamics system may not be saved. This defect could result in the loss of digital medical images, including those used for quantification and report generation.
The syngo Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images. It is not intended for reading mammography images. Users of the affected systems should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the configuration issue.
The recalled product
- Product
- syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo¿ Dynamics is not
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 9
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 (11)
- Model Number: 10091637
- 10091805
- with serial numbers 85164
- 85289
- 85296
- 85297
- 85149
- 85116
- 85177
- 85051
- and 85278.
Distribution
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