Natus Neurology Inc recalls Nicolet¿ Ambulatory EEG

Recall date

February 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2568-2018

FDA classification

Class II

Brand / firm

Natus Neurology Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nicolet¿ Ambulatory EEG