Koven Technology, Inc. recalls Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fet…

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

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.

On March 4, 2026, firm began notifying customers via first-class mail. Customers were informed they may still use the BiDop 3 device for vascular applications, but that the device is not cleared for fetal usage. Koven Technology, Inc. will provide a replacement operation manual for devices that are being amended to remove fetal use indications.

• FDA enforcement recordOfficial FDA database entry for Z-1631-2026
• FDA 510(k) clearance · K954397The device's official FDA premarket clearance record
• FDA device classification · DPWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.2100The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Koven Technology, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.