Siemens syngo.plaza Mammography Software Recall for Image Alignment Issues
Siemens is recalling syngo.plaza software due to potential issues with mammography image laterality and alignment.
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, and the source text describes a potential software display and alignment issue without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity, representing a risk of harm where injury has not yet been reported but is not a critical life-threatening defect.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling six units of syngo.plaza software version VA20 with Mammography license. The recall is due to a potential problem where laterality information in mammography images may not be displayed, and the images may not be properly aligned to mammography segments.
The affected software is distributed nationwide in Florida, Massachusetts, Kansas, New York, Ohio, Pennsylvania, Texas, and Wisconsin. The specific model number is 10592457, and the affected serial numbers include 100219, 100201, 100473, 100177, 100504, 100174, 100181, and 100539.
Siemens issued a Customer Safety Notice to inform customers of this potential problem. Users should contact Siemens for further instructions on how to address the issue.
The recalled product
- Product
- Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 6
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 (8)
- Model number 10592457
- serial numbers 100219
- 100201
- 100504
- 100174
- 100181
- 100473
- and 100539.
Distribution
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