Device 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.
Z-1631-2026
Product summary
- Event
- Event 98556
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 34
- Official record key
device-enforcement:Z-1631-2026
Official wording
Reason: Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Code information: Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
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.
Derived failure modes
-
Unknown
Product labeling includes a fetal indication for use that is not cleared under its 510(k).