Natus Olympic Brainz Monitor Recalled for Missing Functional Tests
Natus Neurology is recalling 40 Olympic Brainz Monitors because required functional tests were not performed before release, meaning the manufacturer cannot verify system functionality.
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. The hazard is a lack of verified functionality due to missing pre-release tests, which is a quality control issue without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk or precautionary recalls.
Plain-English summary
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) is recalling 40 units of the natus newborn care Olympic Brainz Monitor, REF OBM00002. The recall affects specific serial numbers ranging from OBM00002G2119 to OBM00002G2168. These devices are electroencephalographs used for newborn care.
The recall was initiated because the OBM system functional test, which checks impedance and noise, was not carried out on the affected items prior to release to the customer. As a result, the manufacturer cannot attest to the system functionality of these specific units.
The affected units were distributed worldwide, including in the United States, Australia, the Dominican Republic, the United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and the United Kingdom. Users should check their device serial numbers against the provided list and contact the manufacturer for further instructions.
The recalled product
- Product
- natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
- Manufacturer
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Affected units
- 40
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: OBM00002G2119
- OBM00002G2130
- OBM00002G2131
- OBM00002G2132
- OBM00002G2133
- OBM00002G2134
- OBM00002G2135
- OBM00002G2136
- OBM00002G2137
- OBM00002G2138
- OBM00002G2139
- OBM00002G2140
- OBM00002G2141
- OBM00002G2142
- OBM00002G2143
- OBM00002G2144
- OBM00002G2145
- OBM00002G2146
- OBM00002G2147
- OBM00002G2148
Distribution
Distributed nationwide across the United States.
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