FDA Medical Device Recalls (openFDA)
Koven Technology, Inc.: 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.
- Recall number
- Z-1631-2026
- Recalling firm
- Koven Technology, Inc.
- 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 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.
- Status
- Open, Classified
- Initiated
- 2026-03-04
- Posted
- 2026-03-24
- Terminated
- not on file
- Reason
- Product labeling includes a fetal indication for use that is not cleared under its 510(k).
- Root cause
- Labeling Change Control
- 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.
- Quantity
- 34
- Distribution
- US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
- Lot, serial or model codes
- Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
- 510(k) numbers
- ["K954397"]
- PMA numbers
- not on file
- Product code
- DPW
- Firm FEI
- 1937397
- Firm city
- Saint Louis
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28