NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Num
FDA device recall Z-1094-2014 · posted 2014-02-26 · Terminated
Recall details
- Recalling firm
- Hologic, Inc
- Reason for recall
- NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MNB
- Quantity affected
- 93 units
- Distribution
- Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden
- Date initiated
- 2014-01-24
- Date posted
- 2014-02-26
- Date terminated
- 2014-07-17
- Location
- Marlborough, MA
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