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U-systems Recalls

1 recall on record · July 3, 2013 to July 3, 2013 · Medical Devices

July 3, 2013Medical DevicesFDA

U-systems Inc recalls Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography

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].

U-systems Recalls | RecallWatchUSA