Device recall
Z-1767-2008: Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A…
FDA device recall · Class III · Siemens Medical Solutions USA, Inc.
Key facts
| Recall number (Z-number) | Z-1767-2008 |
|---|---|
| Recall event | 47529 |
| Product | Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Imaging, Field Upgrade, PN 07472520. Material number 5936518, 8653771 or 10037593 |
| Product code | IYO |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 30, 2009 |
| 510(k) numbers | K063803 |
| 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