Recall Z-2570-2018— Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Name: FDA recall Z-2570-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-15

Class II · Terminated

Class II FDA medical device recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), initiated 2018-05-15, terminated 2024-05-06. FDA's recall record names no specific 510(k) clearance for this event. Product: XLTEK EMU40EX EEG Headbox. 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..

Recalling firm: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Classification: Class II
Status: Terminated
Initiated: 2018-05-15
Terminated: 2024-05-06
Firm location: Oakville, N/A, Canada

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.