FDA Device recall Z-1587-2013
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound
- FDA Device
- Class II
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class II recall of Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound by U Systems, citing 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) prod….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1587-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-16 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | U Systems |
| Distribution | CA, IL |
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].
Identifiers
| code_info | Serial numbers: H1280099, H1180094, B1380105 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1587-2013%22
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