Recall Z-1094-2014— Hologic, Inc

Name: FDA recall Z-1094-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-24

Class II · Terminated

Class II FDA medical device recall by Hologic, Inc, initiated 2014-01-24, terminated 2014-07-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,.

Recalling firm: Hologic, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-01-24
Terminated: 2014-07-17
Firm location: Marlborough, MA, United States

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.