[pending] Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Mod
Pending LLM rewrite. Source: FDA_DEVICE Z-1631-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
The recalled product
- 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
- Manufacturer
- Koven Technology, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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