FDA-Device2014-03-05Class II
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.
Hologic, Inc
Hazard
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
Sold states
Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden
Affected count
93 units
Manufactured in
250 Campus Dr, Marlborough, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1094-2014Don't want to check this manually?
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