Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 21, 2015
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
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, obscur…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Natus Neurology Inc recalled NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisit… - a moderate-severity action.
NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisit… was recalled by Natus Neurology Inc in October 21, 2015. Reason: When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG…. Check the official notice for the remedy. Verify recall #Z-0117-2016 with the FDA Devices before acting.
The recall
Natus Neurology Inc issued this moderate-severity FDA Devices recall-When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG….
- Moderate
- severity level
- Class II
- classification
- October 21, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0117-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 list the affected scope as 101 (88 US, 13 OUS).
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
101 (88 US, 13 OUS)
Related Recalls
6
3 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.
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 |
| Firm location | Middleton, WI |
| Affected scope | 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0117-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 21, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.