Recall Z-1587-2013— U-systems Inc

Name: FDA recall Z-1587-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-16

Class II · Terminated

Class II FDA medical device recall by U-systems Inc, initiated 2013-05-16, terminated 2013-11-04. It names one FDA 510(k) clearance: K080930. Product: Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.. Reason: 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]..

Recalling firm: U-systems Inc
Classification: Class II
Status: Terminated
Initiated: 2013-05-16
Terminated: 2013-11-04
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K080930 — MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUSU-System, Inc.·cleared 2008-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.

Reason for recall

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].

Data sourced from openFDA. This site is unofficial and independent of the FDA.