Z-2570-2018Class II

XLTEK EMU40EX EEG Headbox

Name: Z-2570-2018 XLTEK EMU40EX EEG Headbox
Creator: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Published: 2018-05-15
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2018-05-15 / Terminated

FDA source

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) began a recall of XLTEK EMU40EX EEG Headbox on 2018-05-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2570-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-15
Posted: 2018-07-28
Terminated: 2024-05-06
Recalling firm: Natus Medical Incorporated
Product: XLTEK EMU40EX EEG Headbox
Product code: GWQ Full-Montage Standard Electroencephalograph
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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 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
Product codes and lots: Part Numbers: 10406, 002933

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2570-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2570-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28

Product code GWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)