Koven Technology, Inc. recalls Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (E
See all recalls from Koven Technology, Inc. →Recalled 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.
Hazard / Issue
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Issued by
FDA
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Brand Name: BiDop 3 →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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