Device recall
Z-0113-2008: GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and…
FDA device recall · Class II · Ge Healthcare
Key facts
| Recall number (Z-number) | Z-0113-2008 |
|---|---|
| Recall event | 39400 |
| Product | GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA. |
| Product code | IYO |
| Recalling firm | Ge Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 21, 2008 |
| 510(k) numbers | K061682 |
| FEI number | 3005860720 |
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