Device recall
Z-1065-2018: ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Recall number (Z-number) | Z-1065-2018 |
|---|---|
| Recall event | 79328 |
| Product | ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological… |
| Product code | IYN |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 2, 2020 |
| 510(k) numbers | K162221 |
| FEI number | 2936884 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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