Device recall
Z-2113-2011: Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through…
FDA device recall · Class II · Digisonics, Inc
Key facts
| Recall number (Z-number) | Z-2113-2011 |
|---|---|
| Recall event | 58367 |
| Product | Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through 4.1.3, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098 OB-Windows provides professional reporting and analysis of fetal growth throughout the gestational period, which can help evaluate clinical situations. OB-View… |
| Product code | LLZ |
| Recalling firm | Digisonics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 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