FDAClass IIAugust 8, 2018

Xltek Emu40ex EEG Headbox recall: Impurity Out of Spec

XLTEK EMU40EX EEG Headbox

Why was Xltek Emu40ex EEG Headbox 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Numbers: 10406, 002933

Product
XLTEK EMU40EX EEG Headbox
Recalling firm
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Quantity
462 Units Total
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
Recall date
August 8, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls