Device recall
Z-1063-2015: ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Recall number (Z-number) | Z-1063-2015 |
|---|---|
| Recall event | 70361 |
| Product | 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 imaging the breast allows volumetric acquisition of the breast image. |
| Product code | IYO |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 10, 2015 |
| 510(k) numbers | K081148 |
| FEI number | 2936884 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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