Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 20, 2013
Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.
Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overhe…
Natus Neurology Incorporated recalled Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 3… - a moderate-severity action.
Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 3… was recalled by Natus Neurology Incorporated in March 20, 2013. Reason: Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become un…. Check the official notice for the remedy. Verify recall #Z-0946-2013 with the FDA Devices before acting.
The recall
Natus Neurology Incorporated issued this moderate-severity FDA Devices recall-Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become un….
- Moderate
- severity level
- Class II
- classification
- March 20, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0946-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0946-2013) was formally reported on March 20, 2013, with the manufacturer initiating the action on February 27, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Natus Neurology Incorporated is listed as the recalling firm, operating out of Middleton, WI. Federal records list the affected scope as 114 (31 USA; 83 OUS).
The documented reason for this recall is: Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging f… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide including the states of CA, FL, LA, MD, MS, MO, NJ, NY, PA, TX and the country of AUSTRALIA. BAHRAIN BRAZIL CANADA Country DENMARK EGYPT GERMANY HONG KONG INDIA INDON…. 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
114 (31 USA; 83 OUS)
Related Recalls
6
3 from same agency
Product description
Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.
Reason for recall
Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0946-2013 |
| Date reported | March 20, 2013 |
| Date initiated | February 27, 2013 |
| Recalling firm | Natus Neurology Incorporated |
| Firm location | Middleton, WI |
| Affected scope | 114 (31 USA; 83 OUS) |
| Distribution | Worldwide Distribution - USA Nationwide including the states of CA, FL, LA, MD, MS, MO, NJ, NY, PA, TX and the country of AUSTRALIA. BAHRAIN BRAZIL CANADA Country DENMARK EGYPT GERMANY HONG KONG INDIA INDONESIA IRELAND ITALY… |
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-0946-2013) 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? ▼
Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.. Recalled by Natus Neurology Incorporated. Units affected: 114 (31 USA; 83 OUS).
Why was this product recalled? ▼
Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2013. Severity: Moderate. Recall number: Z-0946-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide including the states of CA, FL, LA, MD, MS, MO, NJ, NY, PA, TX and the country of AUSTRALIA. BAHRAIN BRAZIL CANADA Country DENMARK EGYPT GERMANY HONG KONG INDIA INDONESIA IRELAND ITALY JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS ROMANIA RUSSIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM URUGUAY VIET NAM.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0946-2013) 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 March 20, 2013. 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.