Reported Oct 21, 2015 · Terminated
NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either…
Natus Neurology Inc.
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 Inc · 3150 Pleasant View Rd · Middleton, WI · 53562-4800
Is this the product you have?
- NicoletOne Software v5.94
- Catalog/Part Number482-649600. 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
- Lot codes and dates
Serial numbers include TS150456MTR150171MTR150172M1TR150173MTR150174MTS150451MTS150452MTR150170MUH150119MTR150169MUR150226MUR150227MUR150228MUR150229MTS150455MTS150457MTS150458MTS150454MTS150453MUC150184MPN151700MSJ150272MTT150134MPN151699MUR150230MUR150231Mand SJ150271M
- Amount recalled
- 101 (88 US, 13 OUS)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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