Hologic Recalls NovaSure Radiofrequency Controllers for Electrical Standard Non-Compliance
Hologic is recalling 93 NovaSure Radiofrequency Controllers because they may not meet the IEC 60601-1 electrical safety standard.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Hologic, Inc. is recalling 93 units of the NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number 71978-001, Catalog Number RFC2009. The recall was initiated because the units may not meet a requirement of the electrical standard IEC 60601-1.
The affected devices were distributed worldwide, including the United States, Canada, France, Germany, and Sweden. The NovaSure system is intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic has identified specific serial numbers for the affected units. Healthcare providers and facilities should check their inventory against the list of serial numbers provided in the official recall notice to determine if they possess affected devices.
The recalled product
- 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…
- Manufacturer
- Hologic, Inc
- Category
- Medical Device — Gynecological
- Affected units
- 93
Distribution
Distributed nationwide across the United States.
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