Koven Technology, Inc. is recalling 34 units of the BiDop 3 Pocket Doppler (Model ES-100V3) that were packaged with a 2 MHz fetal probe (Model BT2M20S8C). These hand-held, battery-powered devices were distributed with labeling that includes indications for fetal use, which have not been cleared by the FDA for this specific model. The device is primarily intended for detecting vascular blood-flow signals in adults and displaying heart rate.
Using a medical device for clinical applications that have not been reviewed or cleared by the FDA may lead to inaccurate readings or inappropriate clinical decisions during fetal monitoring. No injuries or incidents have been reported to date.
Affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.