Z-1587-2013Class II

Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to...

Name: Z-1587-2013 Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to...
Creator: U-systems Inc
Published: 2013-05-16
License: https://open.fda.gov/license/

U-Systems, Inc. / initiated 2013-05-16 / Terminated / root cause: software

FDA source

U-systems Inc began a recall of Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening on 2013-05-16. FDA classified it as Class II and gives the reason as "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]". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1587-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-16
Posted: 2013-06-24
Terminated: 2013-11-04
Recalling firm: U-Systems, Inc.
Product: Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
Product code: PAA Automated Breast Ultrasound
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].
Root cause tag: software
FDA root cause: Software design
Action: On 6/5/13, an "URGENT MEDICAL DEVICE CORRECTION" letter was distributed to all affected users, with a description of the problem and user corrective action steps. One consignee received an Urgent Notice to Customer - Medical Device Correction letter on 5/16/13. Contact the firm at 408-328-7925 for questions regarding this notice.
Quantity in commerce: 3 units
Distribution: Distributed in California and Illinois.
Product codes and lots: Serial numbers: H1280099, H1180094, B1380105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1587-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1587-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-24

Product code PAA

K080930Class IIModification to Automated Breast Ultrasound System, Model AbusU-System, Inc. / cleared 2008-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)