Device recall
Z-1587-2013: Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound…
FDA device recall · Class II · U-systems Inc
Key facts
| Recall number (Z-number) | Z-1587-2013 |
|---|---|
| Recall event | 65371 |
| Product | Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening. |
| Product code | PAA |
| Recalling firm | U-systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2013 |
| 510(k) numbers | K080930 |
| FEI number | 3003248267 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database