Device recall: Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive…
Class II FDA enforcement event 77569. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the user’s ability to clearly hear heart rate and/or blood flow.
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 9 Jun 2017. The firm address in the FDA record is in Middleton, WI. FDA put the recall in Class II. FDA event 77569 has 4 product records. The first FDA enforcement report date is 19 Jul 2017. The record gives the status Terminated, with the termination date 22 Jul 2020.
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, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH , OK, OR, PA,…
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
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2726-2017 | Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. | 2,335 units total | Class II | Terminated | 19 Jul 2017 |
| Z-2727-2017 | Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. | 2,335 units total | Class II | Terminated | 19 Jul 2017 |
| Z-2728-2017 | Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. | 2,335 units total | Class II | Terminated | 19 Jul 2017 |
| Z-2729-2017 | Nicolet Elite 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. | 2,335 units total | Class II | Terminated | 19 Jul 2017 |
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 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 4Median 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 |
| 11 Sep 2015 | NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either wi | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2726-2017The 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 77569. https://recallregister.com/fda/ii/77569/. 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, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH , OK, OR, PA,…
- What quantity of product is in FDA event 77569?
- The event has 4 product records. The first record gives this quantity:
2,335 units total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.