Natus Neurology Recalls Nicolet EEG Wireless Amplifiers Due to Overheating Risk
Natus Neurology is recalling 114 Nicolet EEG Wireless Amplifiers because they may overheat near the on/off button, posing a risk of discomfort or burns.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential for burns) where the source text describes the hazard but does not explicitly report that injuries have occurred, fitting the criteria for a High severity score.
Plain-English summary
Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier, available in 32-channel and 64-channel models. The recall involves 114 units distributed worldwide, including 31 in the United States and 83 outside the U.S.
The recall was initiated because the amplifiers may overheat and become uncomfortable to touch around the area of the on/off button. This overheating may result in discomfort ranging from the device feeling too hot to the potential for a burn.
The affected devices are intended to be used as front-end amplifiers to acquire, store, and transmit electrophysiological signals for the Nicolet Neurodiagnostic system. Consumers and healthcare facilities should check their inventory for the specific catalog numbers listed in the official recall notice and contact Natus Neurology Incorporated for instructions on how to proceed.
The recalled product
- Product
- Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and…
- Manufacturer
- Natus Neurology Incorporated
- Hazard
Distribution
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