FDAFDA · Food and drugs·Recall number Z-2570-2018
XLTEK EMU40EX EEG Headbox
Published August 8, 2018 · Recall initiated: May 15, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Distributor
- 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
- Part Numbers: 10406, 002933
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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