Device recall
Z-0373-2014: GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-0373-2014 |
|---|---|
| Recall event | 66459 |
| Product | GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in… |
| Product code | IYO |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 2015 |
| 510(k) numbers | K120201 |
| FEI number | 2126677 |
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