FDA Device recall Z-1094-2014
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Produc…
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Produc… by Hologic, citing novaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1094-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-24 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hologic |
| Distribution | US |
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,
Identifiers
| code_info | Serial Numbers: 33907H13D0 33911H13D0 33913H13D0 33915H13D0 33917H13D0 33919H13D0 33947I13D0 34014J13D0 34010J…Serial Numbers: 33907H13D0 33911H13D0 33913H13D0 33915H13D0 33917H13D0 33919H13D0 33947I13D0 34014J13D0 34010J13D0 34009J13D0 34011J13D0 33868H13D0 33869H13D0 33870H13D0 33871H13D0 33872H13D0 33873H13D0 33874H13D0 33875H13D0 33876H13D0 33877H13D0 33878H13D0 33879H13D0 33880H13D0 33881H13D0 33882H13D0 33883H13D0 33884H13D0 33885H13D0 33886H13D0 33888H13D0 33889H13D0 33890H13D0 33891H13D0 33892H13D0 33893H13D0 33894H13D0 33895H13D0 33896H13D0 33897H13D0 33898H13D0 33900H13D0 33901H13D0 33902H13D0 33903H13D0 33904H13D0 33948I13D0 33951I13D0 33952I13D0 33953I13D0 33954I13D0 33955I13D0 33956I13D0 33957I13D0 33958I13D0 33959I13D0 33960I13D0 33961I13D0 33962I13D0 33963I13D0 33964I13D0 33965I13D0 33966I13D0 33967I13D0 33968I13D0 33969I13D0 33978J13D0 33979J13D0 33980J13D0 33981J13D0 33982J13D0 33983J13D0 33984J13D0 33990J13D0 33991J13D0 33995J13D0 33997J13D0 33998J13D0 34000J13D0 34001J13D0 34003J13D0 34017K13D0 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1094-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.