Device recall
Z-0713-06: SonoCalc IMT 3.0, a windows based software used in conjunction with images from…
FDA device recall · Class II · Sonosite, Inc.
Key facts
| Recall number (Z-number) | Z-0713-06 |
|---|---|
| Recall event | 34808 |
| Product | SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery. |
| Product code | LLZ |
| Recalling firm | Sonosite, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2006 |
| 510(k) numbers | K030223 |
| FEI number | 3002087856 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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