U-systems Recalls Soma v Automated Breast Ultrasound System for Labeling Error
U-systems Inc is recalling three Soma v Automated Breast Ultrasound Systems because the user manuals incorrectly list the indication for use of a different product model.
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, but the source text identifies the issue as a labeling error (incorrect indication for use in the manual) without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
U-systems Inc is recalling three units of the Soma v Automated Breast Ultrasound System (ABUS). The recall is due to a labeling error where the user manual contains the Indication for Use of the soma v Platinum ABUS, a different 510(k) product, rather than the intended use for the Soma v system.
The affected devices were distributed in California and Illinois. The specific serial numbers for the recalled units are H1280099, H1180094, and B1380105. The Soma v ABUS is indicated as an adjunct to mammography for breast cancer screening.
Consumers and healthcare facilities should check their inventory for these specific serial numbers. If a device is found, it should be removed from service and returned to U-systems Inc in accordance with the recall instructions.
The recalled product
- Product
- Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
- Manufacturer
- U-systems Inc
- Hazard
- Affected units
- 3
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 (3)
- Serial numbers: H1280099
- H1180094
- B1380105
Distribution
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