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.
FDA Recall Z-1631-2026 · Posted 2026-03-24
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Recalling FirmKoven Technology, Inc.
Recall StatusOpen, Classified
Product CodeDPW
Date Initiated2026-03-04
Product Quantity34
Reason for Recall
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Firm Action
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.
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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