Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls XLTEK EMU40EX EEG Headbox

Recall date

May 15, 2018

Source

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

Recall number

Z-2570-2018

FDA classification

Class II

Brand / firm

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Sold / distributed

USA Distribution: AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, ,RI, SC, TN, TX, UT, VA, WA, WI. World wide Distribution: Canada, China, Cyprus, Germany, Hong Kong, Italy, Mexico, Saudi Arabia, Spain, United Kingdom

Why it was recalled

Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting.

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

What was recalled

XLTEK EMU40EX EEG Headbox