Natus Neurology Recalls Nicolet Ambulatory EEG Devices Due to Import Error
Natus Neurology is recalling 171 Nicolet Ambulatory EEG devices because they may allow users to import exams that were not started.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is a software/data import error rather than a direct physical hazard like electrical shock or fire, and no injuries or illnesses are reported in the source text.
Plain-English summary
Natus Neurology Inc is recalling 171 units of the Nicolet Ambulatory EEG device. The recall was initiated because the devices have the potential to allow users to import an ambulatory exam for a patient for which the exam was not started.
The affected devices were distributed domestically to multiple US states including AR, AZ, CA, CO, DC, FL, GA, ID, IL, IN, MA, ME, MI, MO, NY, NC, ND, NJ, NV, PA, TN, TX, VA, WA, and WI. They were also distributed internationally to Australia, Belgium, China, Germany, Hong Kong, Israel, Italy, Jordan, Kuwait, Russia, Slovenia, Tunisia, the United Arab Emirates, and Vietnam.
The FDA has classified this as a Class II recall. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- Nicolet¿ Ambulatory EEG
- Manufacturer
- Natus Neurology Inc
- Category
- Medical Device — Neurology / EEG
- Affected units
- 171
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)
- UDI 00382830043670
- Serial Numbers MBR120693
- MBR100549
- MBR100566
- MBR120699
- MBR090299
- MBR090317
- MBR150907
- MBR100541
- MBR120700
- MBR120681
- MBR120686
- MBR120697
- MBR130793
- MBR110634
- MBR150920
- MBR150921
- MBR160934
- MBR120665
- MBR110629
Distribution
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