Reported Mar 20, 2013 · Terminated

Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and…

Natus Neurology Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Natus Neurology Incorporated · 1850 Deming Way · Middleton, WI · 53562-3530

Is this the product you have?

Nicolet EEG Wireless Amplifier 32/64 Channel
Catalog/Part Numbers515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier
Product UsageThe Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system

Lot codes and dates: 91 of 91 codes
C110318004
C110318027
C110815014
C110815025
C110519011
C110318029
C110318010
C110318028
C110318030
C110318019
C110318006
C110318013
C110519022
C110519021
C110323024
C110323039
C110323037
C110323034
C110519003
C110323011
C110323007
C110815003
C110323040
C110815030
C110815015
C110517040
C110815026
C110519031
C110519030
C110513015
C110519035
C110318009
C110815020
C110519023
C110519023
C110815001
C110519010
C110519017
C110318018
61855
C110519002
C110323006
38249
C110815007
C110323036
C110519007
C110519012
C110519027
C110318008
C110318016
C110318026
C110318027
C110519008
C110519009
C110815023
C110815013
C110519034
C110519029
C110323050
C110118018
&
A4314
C110318014
C110318011
C110318015
34902
C110815011
C110309001
C110519002
A42A0
C110318025
C110519036
C110519028
C110519024
C110519013
C110318005
Amount recalled: 114 (31 USA; 83 OUS)

Where it was sold

Nationwide
CA
FL
LA
MD
MS
MO
NJ
NY
PA
TX

Why it was recalled

Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.

This product could cause temporary or reversible health problems — stop using it.

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By hazard

Where it was distributed

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