Natus Neurology Recalls NicoletOne Software Due to Signal Obstruction
Natus Neurology is recalling NicoletOne Software v5.94 because a persistent impedance check signal obscures EEG data, potentially affecting clinical monitoring.
What this means for you
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 defect involves a software display issue that obscures data without reported injuries or fatalities, fitting the criteria for a moderate severity recall.
Plain-English summary
Natus Neurology Inc is recalling 101 units of NicoletOne Software v5.94 (Catalog/Part Number: 482-649600). The software is a data acquisition and review system intended for medical purposes to record, measure, store, and display full band cerebral EEG and extracerebral activity. The affected units were distributed worldwide, including in the United States, India, Romania, Denmark, Japan, Australia, Russia, Bangladesh, Sri Lanka, Brunei, and the United Arab Emirates.
The recall is due to a software defect where the impedance check signal remains active in the waveform after the user exits the impedance check function and returns to the EEG screen. This persistent signal obscures the EEG signals, which may interfere with the system's intended use for clinical EEG, electrocorticography, long-term monitoring, intensive care unit monitoring, and polysomnography sleep studies.
Healthcare facilities and users should contact Natus Neurology Inc for instructions on how to resolve the issue. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and e
- Manufacturer
- Natus Neurology Inc
- Category
- Medical Device — EEG Software
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers include TS150456M
- TR150171M
- TR150172M
- 1TR150173M
- TR150174M
- TS150451M
- TS150452M
- TR150170M
- UH150119M
- TR150169M
- UR150226M
- UR150227M
- UR150228M
- UR150229M
- TS150455M
- TS150457M
- TS150458M
- TS150454M
- TS150453M
- UC150184M
Distribution
Distributed nationwide across the United States.
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