BEUDAMED
    FDA Recall 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.

    Recall: Z-0232-04 · Initiated December 5, 2003

    Recall

    Recall Number
    Z-0232-04
    Event Number
    27882
    Firm
    Danatech Medical Systems Inc
    FEI Number
    1000541224
    Product Code
    MAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 5, 2003
    Posted
    July 20, 2004
    Terminated
    October 5, 2009
    Address
    7275 Nw 68th St, Ste 1, Miami, FL, 33166-3094

    Description

    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.

    Reason

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

    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.

    Distribution

    Product was distributed to 89 consumers nationwide.

    Quantity

    89 units