Device recall
Z-1581-2015: ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Recall number (Z-number) | Z-1581-2015 |
|---|---|
| Recall event | 71116 |
| Product | ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral… |
| Product code | IYO |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 6, 2015 |
| 510(k) numbers | K123622 |
| 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