FDA Medical Device Recalls (openFDA)
U-systems Inc: Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
- Recall number
- Z-1587-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-05-16
- Posted
- 2013-06-24
- Terminated
- 2013-11-04
- 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].
- 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
- 3 units
- Distribution
- Distributed in California and Illinois.
- Lot, serial or model codes
- Serial numbers: H1280099, H1180094, B1380105
- 510(k) numbers
- ["K080930"]
- PMA numbers
- ["P110006"]
- Product code
- PAA
- Firm FEI
- 3003248267
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28