BiDop 3 pocket Doppler labeling includes uncleared fetal indication
Koven Technology is recalling the BiDop 3 Pocket Doppler packaged with a fetal probe because the product labeling includes a fetal indication for use that is not cleared under its 510(k).
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers voluntary precautionary recalls: the recall concerns an indication on the labeling that falls outside the device's clearance, and the source describes no defect or malfunction.
Plain-English summary
Koven Technology, Inc. is recalling the BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe. The device is a hand-held, battery-powered ultrasonic Doppler blood-flow detector with an 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 labelled for both vascular and fetal applications. About 34 units were distributed across sixteen US states. The FDA has classified this recall as Class II.
The product labeling includes a fetal indication for use that is not cleared under its 510(k). The source record does not describe a defect or malfunction in the device itself.
Affected product carries codes 00894912002043 for the BiDop 3 and 00894912002326 for the BT2M20S8C probe.
Facilities can identify affected units by the model numbers above, and may contact Koven Technology, Inc. for further information.
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 — Doppler
- Affected units
- 34
Distribution
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