Device recall
Z-2193-2011: Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5…
FDA device recall · Class II · Digisonics, Inc
Key facts
| Recall number (Z-number) | Z-2193-2011 |
|---|---|
| Recall event | 58421 |
| Product | Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098, Tel: (800) 940-3240, Fax: (713) 529-7999 Software used to make on-screen (2-D, M-Mode and Doppler) measurements of left ventricle, right ventricle, etc. |
| Product code | LLZ |
| Recalling firm | Digisonics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2011 |
| 510(k) numbers | K970402 |
| FEI number | 1626313 |
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