Natus Neurology Inc: Medical Device Recall in 2015 - (Recall #: Z-0117-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display data

Product Classification:

Class II

Date Initiated: September 11, 2015

Date Posted: October 21, 2015

Recall Number: Z-0117-2016

Event ID: 71991

Reason for Recall:

When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals.

Status: Terminated

Product Quantity: 101 (88 US, 13 OUS)

Code Information:

Serial numbers include TS150456M, TR150171M, TR150172M, 1TR150173M, TR150174M, TS150451M, TS150452M, TR150170M, UH150119M, TR150169M, UR150226M, UR150227M, UR150228M, UR150229M, TS150455M, TS150457M, TS150458M, TS150454M, TS150453M, UC150184M, PN151700M, SJ150272M, TT150134M, PN151699M, UR150230M, UR150231M, and SJ150271M.

Distribution Pattern:

Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.

Voluntary or Mandated:

Voluntary: Firm initiated