Danatech Medical Systems Inc Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models.
Brand
Danatech Medical Systems Inc
Lot Codes / Batch Numbers
Product is uncoded.
Products Sold
Product is uncoded.
Danatech Medical Systems Inc is recalling Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rat due to This prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
This prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet.
Recommended Action
Per FDA guidance
The firm mailed via overnight priority mail, a recall notification letter with response form to consignees on 12/5/2003 requesting return of the product and refund.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026