BEUDAMED
    FDA Recall Terminated

    OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098 OBLink provides automated transmission of patient data and measurements from ultrasound systems directly to Digisonics OB-View/OB-Windows systems.

    Recall: Z-2066-2011 · Initiated May 12, 2008

    Recall

    Recall Number
    Z-2066-2011
    Event Number
    58371
    Firm
    Digisonics, Inc
    FEI Number
    1626313
    Product Code
    HEM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 12, 2008
    Posted
    April 26, 2011
    Terminated
    May 2, 2011
    Address
    3701 Kirby Dr, Ste 930, Houston, TX, 77098-3922

    Description

    OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098 OBLink provides automated transmission of patient data and measurements from ultrasound systems directly to Digisonics OB-View/OB-Windows systems.

    Reason

    Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report

    Action

    Digisonics visited consignee in April 2008 as follow-up to complaint.

    Distribution

    Nationwide Distribution including OK

    Quantity

    2 units