Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

XLTEK EMU40EX EEG Headbox

FDA Recall Z-2570-2018 · Posted None

Recalling FirmNatus Neurology DBA Excel Tech., Ltd. (XLTEK)
Recall StatusTerminated
Product CodeGWQ
Date Initiated2018-05-15
Date Terminated2024-05-06
Product Quantity462 Units Total

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.

Firm 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.

Root Cause

Other

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑