Recall Z-1094-2014 ยท MNB Device, Thermal Ablation, Endometrial
Hologic, Inc
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.
| Date | Feb 26, 2014 (initiated Jan 24, 2014) |
| Status | Terminated |
| Reason | NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, |
| Root cause | Component design/selection |
| Action | Hologic sent an Important Medical Device Information letter to all affected consignees on January 24, 2014 via certified letter. The letter contains instructions for scheduling the return and replacement of the affected unit, provides contact information, and includes a postage-paid return card for the consignee to complete and return to Hologic. |
| Quantity | 93 units |
| Distribution | Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.