Device product
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
Z-0117-2016
Product summary
- Event
- Event 71991
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101 (88 US, 13 OUS)
- Official record key
device-enforcement:Z-0117-2016
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.