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.
FDA Recall Z-1094-2014 · Posted 2014-02-26
Recalling FirmHologic, Inc
Recall StatusTerminated
Product CodeMNB
Date Initiated2014-01-24
Date Terminated2014-07-17
Product Quantity93 units
Reason for Recall
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.