Device recall
Z-0232-04: Product is a handheld fetal Doppler used to screen for fetal heart rate and…
FDA device recall · Class II · Danatech Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-0232-04 |
|---|---|
| Recall event | 27882 |
| Product | Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models. |
| Product code | MAA |
| Recalling firm | Danatech Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2009 |
| FEI number | 1000541224 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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