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.
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, 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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