Z-0232-04

Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is...

Name: Z-0232-04 Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is...
Creator: Danatech Medical Systems Inc
Published: 2003-12-05
License: https://open.fda.gov/license/

Danatech Medical Systems Inc / initiated 2003-12-05 / Terminated

FDA source

Danatech Medical Systems Inc began a recall of 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... on 2003-12-05. The reason FDA records is "This prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0232-04
Status: Terminated
Initiated: 2003-12-05
Posted: 2004-07-20
Terminated: 2009-10-05
Recalling firm: Danatech Medical Systems Inc
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.
Product code: MAA Monitor, Fetal Doppler Ultrasound
Reason for recall: This prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet.
FDA root cause: Other
Action: 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.
Quantity in commerce: 89 units
Distribution: Product was distributed to 89 consumers nationwide.
Product codes and lots: Product is uncoded.

Product code MAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)