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.
Reported: March 5, 2014 Initiated: January 24, 2014 #Z-1094-2014
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,
Details
- Recalling Firm
- Hologic, Inc
- Units Affected
- 93 units
- Distribution
- Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hologic, Inc. Units affected: 93 units.
Why was this product recalled? ▼
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1094-2014.
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