Z-1631-2026
Class II · Ongoing
- Recalling firm
- Koven Technology, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 20260304
- Firm location
- Saint Louis, MO, United States
Product description
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 display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
Reason for recall
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Data sourced from openFDA. This site is unofficial and independent of the FDA.