RecallDepth

XLTEK EMU40EX EEG Headbox

Company
Natus Neurology Dba Excel Tech., Ltd. (Xltek)
Recall Initiated
May 15, 2018
Terminated
May 6, 2024
Recall Number
Z-2570-2018
Quantity
462 Units Total
Firm Location
Oakville Canada

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

Lot / Code Info

Part Numbers: 10406, 002933

Root Cause

Other

Action Taken

Natus Neurology notified customers on or about 05/15/2018, via Advisory Notification Letter to stop using the device immediately and contact Natus regarding replacement options. Customers were advised that if the malfunction occurs, to immediately cease using the device and contact Natus for replacement. Customers were also instructed to communicate the notification to all applicable users and to complete and return the advisory verification form.

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