Drug recall
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to…
FDA recall event 65371 · Class II · U-systems Inc
Key facts
| Event ID | 65371 |
|---|---|
| Recall numbers | Z-1587-2013 |
| Recalling firm | U-systems Inc |
| Product type | Devices |
| Products | Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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]. |
| Initiation date | May 16, 2013 |
| Report date | Jul 3, 2013 |
| Termination date | Nov 4, 2013 |
| City | Sunnyvale |
| State | CA |
| Country | United States |
| FEI number | 3003248267 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: