FDASeptember 11, 2015device
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 activ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
natus neurologynatus
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANatus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph2025-06-18
- FDABrand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No2025-05-07
- FDATENSIVE Conductive Adhesive Gel, REF 016-4016002024-02-07
- FDAnatus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 0242522024-02-07
- FDAEDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only2023-11-28
- FDAExternal Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only2023-11-28
- FDAThe Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of th...2022-11-18
- FDAIPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software2021-12-02
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