Z-2570-2018 Class II Terminated
FDA device recall Z-2570-2018 was initiated by Natus Neurology DBA Excel Tech., Ltd. (XLTEK) on May 15, 2018 and is designated Class II. 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. The recall status is terminated (terminated May 6, 2024). Affected quantity: 462 Units Total.
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- May 15, 2018
- Termination Date
- May 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 462 Units Total
Product Description
XLTEK EMU40EX EEG Headbox
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.
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
Code Information
Part Numbers: 10406, 002933