Home / Recalls / Medical Devices
Hologic, Inc recalls NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Nu
Recalled March 5, 2014 · FDA recall Z-1094-2014 · Hologic
Hazard
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, · FDA Class II
Units
93 units
Sold at
Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden
Description
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
Product
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(s)
Hologic, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →