Device recall
Z-2061-2011: Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and…
FDA device recall · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Recall number (Z-number) | Z-2061-2011 |
|---|---|
| Recall event | 53053 |
| Product | Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01 (model numbers 10348531, 10348532 and 10348533), when using the V5Ms transducer (model number 08263703) and the Plus option (10427795) Product is an ultrasound imaging system intended for General Radiology,Fetal… |
| Product code | IYO |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2011 |
| 510(k) numbers | K072676 |
| 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