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Recall Observatory FDA recall evidence

Device product

XLTEK EMU40EX EEG Headbox

Z-2570-2018

May 15, 2018

Class II

Product summary

Firm
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Event
Event 80239
Status
Terminated
Classification
Class II
Quantity
462 Units Total
Official record key
device-enforcement:Z-2570-2018

Official wording

Reason: 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.

Code information: Part Numbers: 10406, 002933

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.