FDA recall Z-2570-2018

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) · Class II · device

Product

XLTEK EMU40EX EEG Headbox

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-05-15
Report date
2018-08-08
Termination date
2024-05-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oakville, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2570-2018