Events

Recall of Device Recall NovaSure Radiofrequency Control Units

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hologic, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67375
  • Event Risk Class
    Class 2
  • Event Number
    Z-1094-2014
  • Event Initiated Date
    2014-01-24
  • Event Date Posted
    2014-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125361
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, thermal ablation, endometrial - Product Code MNB
  • 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.

Device

Device Recall NovaSure Radiofrequency Control Units
  • Model / Serial
    Serial Numbers: 33907H13D0 33911H13D0 33913H13D0 33915H13D0 33917H13D0 33919H13D0 33947I13D0 34014J13D0 34010J13D0 34009J13D0 34011J13D0 33868H13D0 33869H13D0 33870H13D0 33871H13D0 33872H13D0 33873H13D0 33874H13D0 33875H13D0 33876H13D0 33877H13D0 33878H13D0 33879H13D0 33880H13D0 33881H13D0 33882H13D0 33883H13D0 33884H13D0 33885H13D0 33886H13D0 33888H13D0 33889H13D0 33890H13D0 33891H13D0 33892H13D0 33893H13D0 33894H13D0 33895H13D0 33896H13D0 33897H13D0 33898H13D0 33900H13D0 33901H13D0 33902H13D0 33903H13D0 33904H13D0 33948I13D0 33951I13D0 33952I13D0 33953I13D0 33954I13D0 33955I13D0 33956I13D0 33957I13D0 33958I13D0 33959I13D0 33960I13D0 33961I13D0 33962I13D0 33963I13D0 33964I13D0 33965I13D0 33966I13D0 33967I13D0 33968I13D0 33969I13D0 33978J13D0 33979J13D0 33980J13D0 33981J13D0 33982J13D0 33983J13D0 33984J13D0 33990J13D0 33991J13D0 33995J13D0 33997J13D0 33998J13D0 34000J13D0 34001J13D0 34003J13D0 34017K13D0 34021K13D0 34023K13D0 34026K13D0 34027K13D0 34028K13D0 34029K13D0 34031K13D0 34032K13D0 34033K13D0 34035K13D0 34039K13D0
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden
  • Product 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.
  • Manufacturer
    Hologic, Inc

Manufacturer

Hologic, Inc
  • Manufacturer Address
    Hologic, Inc, 250 Campus Dr, Marlborough MA 01752-3020
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA