Recall Z-2570-2018 ยท GWQ Full-Montage Standard Electroencephalograph
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
XLTEK EMU40EX EEG Headbox
| Date | May 15, 2018 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.