Device recall
Z-1838-2011: ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc., Mountain View, CA
Key facts
| Recall number (Z-number) | Z-1838-2011 |
|---|---|
| Recall event | 56840 |
| Product | ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed; ACUSON X300: 10037409, 10132987, 10038837; SONOVISTA X300: 10133170; ACUSON X300 PE: 10348531, 10348532, 10348533; X300 Cardiovascular Options: 10133037, 10348777, 10349032, 10427797, 10427822, 10427816… |
| Product code | ITX |
| Recalling firm | Siemens Medical Solutions USA, Inc., Mountain View, CA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 18, 2012 |
| 510(k) numbers | K072676 |
| 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