FDA Medical Device Recalls (openFDA)
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 number
- Z-0232-04
- 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.
- Status
- Terminated
- Initiated
- 2003-12-05
- Posted
- 2004-07-20
- Terminated
- 2009-10-05
- Reason
- This prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet.
- 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
- 89 units
- Distribution
- Product was distributed to 89 consumers nationwide.
- Lot, serial or model codes
- Product is uncoded.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MAA
- Firm FEI
- 1000541224
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28