Reported Mar 5, 2014 · Terminated
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 250 Campus Dr · Marlborough, MA · 01752-3020
Is this the product you have?
- NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller
- Model Number71978-001
- Catalog NumberRFC2009
- Product UsageThe 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
- Lot codes and dates
- Serial Numbers
93 of 93 codes
33907H13D033911H13D033913H13D033915H13D033917H13D033919H13D033947I13D034014J13D034010J13D034009J13D034011J13D033868H13D033869H13D033870H13D033871H13D033872H13D033873H13D033874H13D033875H13D033876H13D033877H13D033878H13D033879H13D033880H13D033881H13D033882H13D033883H13D033884H13D033885H13D033886H13D033888H13D033889H13D033890H13D033891H13D033892H13D033893H13D033894H13D033895H13D033896H13D033897H13D033898H13D033900H13D033901H13D033902H13D033903H13D033904H13D033948I13D033951I13D033952I13D033953I13D033954I13D033955I13D033956I13D033957I13D033958I13D033959I13D033960I13D033961I13D033962I13D033963I13D0
- Serial Numbers
- Amount recalled
- 93 units
Where it was sold
- Nationwide
Why it was recalled
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
This product could cause temporary or reversible health problems — stop using it.
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