Device recall
Z-1631-2026: Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with…
FDA device recall · Class II · Koven Technology, Inc.
Key facts
| Recall number (Z-number) | Z-1631-2026 |
|---|---|
| Recall event | 98556 |
| Product | Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric… |
| Product code | DPW |
| Recalling firm | Koven Technology, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K954397 |
| FEI number | 1937397 |
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