Device recall
Z-0004-2011: AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects…
FDA device recall · Class II · Verathon, Inc.
Key facts
| Recall number (Z-number) | Z-0004-2011 |
|---|---|
| Recall event | 56411 |
| Product | AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements |
| Product code | IYO |
| Recalling firm | Verathon, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 8, 2011 |
| 510(k) numbers | K082456 |
| FEI number | 3022472 |
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