Class II — U-systems Inc
| Recalling firm | Z-SYSTEMS AG |
|---|---|
| Registered facility | Z-SYSTEMS AG (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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]. |
| Product | Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening. |
| Quantity | 3 units |
| Distribution | Distributed in California and Illinois. |
| Initiated | 2013-05-16 |
| Classified | 2013-06-24 |
| Terminated | 2013-11-04 |
| Recall number | Z-1587-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — U-systems Inc (Z-1587-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65371/
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