Siemens Recalls SYNGO Breast Care Software Due to Display Issues
Siemens is voluntarily recalling 29 units of SYNGO Breast Care software because patient information can obscure view markers and facility details are not shown by default.
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 involves a voluntary precautionary recall for software display issues that do not explicitly report injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is voluntarily recalling 29 units of SYNGO Breast Care software. This software provides visualization and image enhancement tools to assist radiologists in reviewing digital mammography images and tomosynthesis datasets.
The recall was initiated due to specific software behavior issues. First, the view and laterality marker can be overlaid by patient demographic information, making it difficult to read. Second, the facility name and address are not displayed by default; in the current software versions, this information is only visible when the reader selects an appropriate image text display mode.
The affected units were distributed to facilities in California, New York, Texas, Ohio, Colorado, Nebraska, New Jersey, Florida, Illinois, Missouri, Pennsylvania, and North Dakota. Siemens is the recalling firm.
The recalled product
- Product
- SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Affected units
- 29
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)
- Device Model # 10496180 Serial Numbers: 221176
- 130159
- 130773
- 100641
- 100642
- 100643
- 100644
- 100645
- 100811
- 100812
- 100813
- 100814
- 221129
- 130326
- 221192
- 130201
- 220930
- 130438
- 102113
- 130635
Distribution
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