Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Soma v Automated Breast Ultrasound System (ABUS) Recalled by U-systems Inc Due to Devices labeled for an intended use not included...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact U-systems Inc directly.
Affected Products
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
Quantity: 3 units
Why Was This Recalled?
Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].
Where Was This Sold?
Distributed in California and Illinois.
About U-systems Inc
U-systems Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report