FDA Device recall Z-0946-2013

Nicolet EEG Wireless Amplifier 32/64 Channel

FDA Device
Class II
terminated
Published 2013-03-20

On 2013-03-20 the FDA classified a Class II recall of Nicolet EEG Wireless Amplifier 32/64 Channel by Natus Neurology, citing 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 overhea….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0946-2013
Classification	Class II
Status	terminated
Initiated	2013-02-27
Published	2013-03-20
Last updated	2026-09-13 11:53 UTC
Company	Natus Neurology
Distribution	US

Product

Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The 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.

Reason

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.

Identifiers

code_info	C110318004 C110318027 C110815014 C110815025 C110519011 C110318029 C110318010 C110318028 C110318030 C110318019… 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 C110519043 C110815027 C110519005 C110519026 C110579013 C110519045 C110519015 C110201021 C110318001 C110519050 C110323002 C110519014 C110519033 C110318012 C110519038 C110519042 C110318023 C110519020 RG100512M C110519046 C110519037 C110519019 C110519007 C1

code_info

C110318004 C110318027 C110815014 C110815025 C110519011 C110318029 C110318010 C110318028 C110318030 C110318019…

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 C110519043 C110815027 C110519005 C110519026 C110579013 C110519045 C110519015 C110201021 C110318001 C110519050 C110323002 C110519014 C110519033 C110318012 C110519038 C110519042 C110318023 C110519020 RG100512M C110519046 C110519037 C110519019 C110519007 C1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0946-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.