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Terminated

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.

FDA Recall Z-0232-04 · Posted 2004-07-20

Recalling FirmDanatech Medical Systems Inc
Recall StatusTerminated
Product CodeMAA
Date Initiated2003-12-05
Date Terminated2009-10-05
Product Quantity89 units

Reason for Recall

This prescription device, without an approved 510K , was distributed to unauthorized consumers, mostly pregnant women, on the internet.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was distributed to 89 consumers nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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