Natus Neurology Inc recalls Nicolet¿ Ambulatory EEG

Recalled August 8, 2018 · FDA recall Z-2568-2018 · Natus Neurology

Hazard

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

Units

171 units

Sold at

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.

Description

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

Product

Nicolet¿ Ambulatory EEG

Manufacturer(s)

Natus Neurology Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →