BEUDAMED
    FDA Recall Terminated

    NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

    Recall: Z-1094-2014 · Initiated January 24, 2014

    Recall

    Recall Number
    Z-1094-2014
    Event Number
    67375
    Firm
    Hologic, Inc
    FEI Number
    1000120743
    Product Code
    MNB
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 24, 2014
    Posted
    February 26, 2014
    Terminated
    July 17, 2014
    Address
    250 Campus Dr, Marlborough, MA, 01752-3020

    Description

    NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

    Reason

    NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,

    Action

    Hologic sent an Important Medical Device Information letter to all affected consignees on January 24, 2014 via certified letter. The letter contains instructions for scheduling the return and replacement of the affected unit, provides contact information, and includes a postage-paid return card for the consignee to complete and return to Hologic.

    Distribution

    Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden

    Quantity

    93 units