Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0117-2016 · Posted 2015-10-13

Recalling FirmNatus Neurology Inc
Recall StatusTerminated
Product CodeGWQ
Date Initiated2015-09-11
Date Terminated2016-03-08
Product Quantity101 (88 US, 13 OUS)

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.

Firm 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.

Root Cause

Software change control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964280DG NERVUSMedelec , Ltd. · 1997-01-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑