Device recall: NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either…
Class II FDA enforcement event 71991. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Natus Neurology Inc started this device recall on 11 Sep 2015. The firm address in the FDA record is in Middleton, WI. FDA put the recall in Class II. FDA event 71991 has 1 product record. The first FDA enforcement report date is 21 Oct 2015. The record gives the status Terminated, with the termination date 8 Mar 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.
Recalling firm
Natus Neurology Inc, Middleton, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0117-2016 | 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,… | 101 (88 US, 13 OUS) | Class II | Terminated | 21 Oct 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 2
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Feb 2024 | TENSIVE Conductive Adhesive Gel, REF 016-401600 | Device | Class II | 2 |
| 1 Feb 2018 | Nicolet Ambulatory EEG | Device | Class II | 1 |
| 9 Jun 2017 | Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, | Device | Class II | 4 |
Official channels
- FDA enforcement report Z-0117-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 71991. https://recallregister.com/fda/ii/71991/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.
- What quantity of product is in FDA event 71991?
- The FDA record gives this quantity:
101 (88 US, 13 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.