XLTEK EMU40EX EEG Headbox Recalled for Component Degradation
Natus Neurology is recalling 462 XLTEK EMU40EX EEG Headboxes because an internal electronic component may degrade, causing the unit to overheat and the plastic case to melt.
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 medical device with a risk of harm (overheating and melting) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) is recalling 462 units of the XLTEK EMU40EX EEG Headbox. The recall is due to a possible degradation of an internal electronic component over time, which may cause the device to fail. When this failure occurs, the device may feel hot and the plastic case may start melting.
The affected units were distributed across 30 states in the United States, including Alabama, California, and Texas, as well as in Canada, China, Cyprus, Germany, Hong Kong, Italy, Mexico, Saudi Arabia, Spain, and the United Kingdom. The specific part numbers for the recalled items are 10406 and 002933.
Consumers and healthcare providers should stop using the affected EEG Headboxes immediately. Users should contact Natus Neurology for instructions on how to return or replace the device.
The recalled product
- Product
- XLTEK EMU40EX EEG Headbox
- Manufacturer
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Hazard
- Affected units
- 462
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 (2)
- Part Numbers: 10406
- 002933
Distribution
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