# FDA recall Z-2568-2018

> **Natus Neurology Inc** · Class II · device recall initiated 2018-02-01.

## Product

Nicolet¿ Ambulatory EEG

## Reason for recall

Potential to be able to import an ambulatory exam for a patient for which the exam was not started.

## Distribution

Distributed domestically to AR, AZ, CA, CO, DC, FL, GA, ID, IL, IN, MA, ME, MI, MO, N Y, NC, ND, NJ, NV, NY, PA, TN, TX, VA, WA, WI.      Distributed internationally to Australia, Belgium, China, Germany, Hong Kong, Israel, Italy, Jordan, Kuwait, Russia, Slovenia, Tunisia, United Arab Emirates, Vietnam.

## Key facts

- **Recall number:** Z-2568-2018
- **Recalling firm:** Natus Neurology Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-01
- **Report date:** 2018-08-08
- **Termination date:** 2022-10-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Middleton, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2568-2018

## Citation

> AI Analytics. FDA recall Z-2568-2018. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-2568-2018. Source: US FDA. Licensed CC0.

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