Z-0117-2016Class II

NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review...

Name: Z-0117-2016 NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review...
Creator: Natus Neurology Inc
Published: 2015-09-11
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-09-11 / Terminated / root cause: software

FDA source

Natus Neurology Inc began a recall of NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital... on 2015-09-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0117-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-11
Posted: 2015-10-13
Terminated: 2016-03-08
Recalling firm: Medtronic, Inc.
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
Product code: GWQ Full-Montage Standard Electroencephalograph
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.
Root cause tag: software
FDA root cause: Software change control
Action: 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.
Quantity in commerce: 101 (88 US, 13 OUS)
Distribution: Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0117-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0117-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-13

Product code GWQ

K964280Class IIDg NervusMedelec , Ltd. / cleared 1997-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)