Recall Z-0946-2013— Natus Neurology Incorporated

Name: FDA recall Z-0946-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-27

Class II · Terminated

Class II FDA medical device recall by Natus Neurology Incorporated, initiated 2013-02-27, terminated 2014-04-25. It names one FDA 510(k) clearance: K103140. 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..

Recalling firm: Natus Neurology Incorporated
Classification: Class II
Status: Terminated
Initiated: 2013-02-27
Terminated: 2014-04-25
Firm location: Middleton, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K103140 — NICOLET WIRELESS EEGCarefusion 209, Inc.·cleared 2011-04-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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.

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