BEUDAMED
    FDA Recall Terminated

    HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)

    Recall: Z-0691-2007 · Initiated January 24, 2007

    Recall

    Recall Number
    Z-0691-2007
    Event Number
    37291
    Firm
    Boston Scientific Corporation One Boston
    FEI Number
    3001451463
    Product Code
    MNB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 24, 2007
    Posted
    March 31, 2007
    Terminated
    December 12, 2007
    Address
    Scientific Place Natick, MA, 01760-1536

    Description

    HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)

    Reason

    Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment

    Action

    Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and return product.

    Distribution

    Worldwide-USA, UK, Denmark, Italy, and France

    Quantity

    2 units