Soma v Automated Breast Ultrasound System — Class II medical device recall Z-1587-2013
Terminated recall by U-systems Inc, reported 2013-07-03, distributed in CA, IL. Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual conta
| Recall number | Z-1587-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | U-systems Inc, Sunnyvale, CA, United States |
| Recall initiated | 2013-05-16 |
| Classified | 2013-06-24 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2013-11-04 |
| Distributed | CA, IL |
| Quantity | 3 units |
| Reason classes | labeling |
| Serial numbers | B1380105, H1180094, H1280099 |
Product
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].
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1587-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.