Severity
Moderate
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
Reported: October 21, 2015 Initiated: September 11, 2015 #Z-0117-2016 101 (88 US, 13 OUS) units
Natus Neurology Inc issued this FDA Devices recall on October 21, 2015. Classified as Moderate severity (Class II). Approximately 101 (88 US, 13 OUS) units are affected. The recall was issued because: When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, t…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0117-2016) was formally reported on October 21, 2015, with the manufacturer initiating the action on September 11, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Natus Neurology Inc is listed as the recalling firm, operating out of Middleton, WI. Federal records indicate 101 (88 US, 13 OUS) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
101 (88 US, 13 OUS)
Related Recalls
6
6 from same agency
Product Description
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
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.
Details
- Recalling Firm
- Natus Neurology Inc
- Units Affected
- 101 (88 US, 13 OUS)
- Distribution
- Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.
- Location
- Middleton, WI
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0117-2016 |
| Date reported | October 21, 2015 |
| Date initiated | September 11, 2015 |
| Recalling firm | Natus Neurology Inc |
| Units affected | 101 (88 US, 13 OUS) |
| Distribution | Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Natus Neurology Inc. Units affected: 101 (88 US, 13 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 21, 2015. Severity: Moderate. Recall number: Z-0117-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0117-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).