U-systems Inc: Medical Device Recall in 2013 - (Recall #: Z-1587-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 16, 2013

Date Posted: July 3, 2013

Recall Number: Z-1587-2013

Event ID: 65371

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].

Status: Terminated

Product Quantity: 3 units

Code Information:

Serial numbers: H1280099, H1180094, B1380105

Distribution Pattern:

Distributed in California and Illinois.

Voluntary or Mandated:

Voluntary: Firm initiated