Drug recall
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are…
FDA recall event 70361 · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Event ID | 70361 |
|---|---|
| Recall numbers | Z-1063-2015 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Product type | Devices |
| Products | ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a low probability the scanner arm will become completely detached from the scanner column. |
| Initiation date | Jan 12, 2015 |
| Report date | Feb 18, 2015 |
| Termination date | Jun 10, 2015 |
| City | Mountain View |
| State | CA |
| Country | United States |
| FEI number | 2936884 |
At a glance
- 1–9 Products in this recall
- 10–99 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: