FDA Medical Device Recalls (openFDA)
Natus Neurology DBA Excel Tech., Ltd. (XLTEK): XLTEK EMU40EX EEG Headbox
- Recall number
- Z-2570-2018
- Recalling firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Product
- XLTEK EMU40EX EEG Headbox
- Status
- Terminated
- Initiated
- 2018-05-15
- Posted
- not on file
- Terminated
- 2024-05-06
- 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.
- 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
- 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
- Lot, serial or model codes
- Part Numbers: 10406, 002933
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GWQ
- Firm FEI
- 3002809369
- Firm city
- Oakville
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28