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
This recall has been terminated (originally issued October 13, 2015).
- Company
- Natus Neurology Inc
- Recall Initiated
- September 11, 2015
- Posted
- October 13, 2015
- Terminated
- March 8, 2016
- Recall Number
- Z-0117-2016
- Quantity
- 101 (88 US, 13 OUS)
- Firm Location
- Middleton, WI
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.
Lot / Code Info
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.
Root Cause
Software change control
Action Taken
Natus Neurology sent an Ugent Medical Device Corrrection Notification letter dated September 9, 2015 to all affected consignees. The letter described the problem and the product involved in the recall. Consignees were informed consignees that a Field Service Technician will contact them to install the new software. Once the software is installed they will ask the Recipient or Field service Technician to complete and return the Verification Form. For questions regarding this recall call 608-829-8600.