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U-systems Inc recalls Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography
Recalled July 3, 2013 · FDA recall Z-1587-2013 · U-systems
Hazard
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]. · FDA Class II
Units
3 units
Sold at
Distributed in California and Illinois.
Description
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].
Product
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
Manufacturer(s)
U-systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →