NATUS NEUROLOGY X1L001Recalls & reported problems
Natus Neurology Incorporated · ELITE 3MHZ OB PROBE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Natus Neurology ELITE OB probe has 39 adverse event reports that mostly describe excessive static noise in the probe, with no deaths and no injuries. There are no recalls that name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00382830028233), received between Jun 20, 2017 and Jun 29, 2017 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (39 reports).
4 other recalls cover devices cleared under the same FDA submission (K982635); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Sensing Problem39
Patient problems
- No Known Impact Or Consequence To Patient39
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6678857 ↗MalfunctionJun 29, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6678839 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656808 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656805 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656795 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656793 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656792 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656790 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656781 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656780 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656774 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656765 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656762 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656761 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656758 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656755 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656752 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656751 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656750 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656748 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656744 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656743 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656742 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656737 ↗MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem
EXCESSIVE STATIC NOISE OBSERVED IN ELITE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6656733 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K982635. One submission often covers many models, so check the product and lot details in each record.
- Z-2729-2017 · Jun 9, 2017 · TerminatedNicolet 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
- Z-2726-2017 · Jun 9, 2017 · TerminatedNicolet 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 bef
- Z-2728-2017 · Jun 9, 2017 · TerminatedNicolet 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 surge
- Z-2727-2017 · Jun 9, 2017 · TerminatedNicolet 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
Other Monitor, Ultrasonic, Nonfetal devices
- NATUS NEUROLOGY X1L004Natus Neurology Incorporated · Monitor, Ultrasonic, Nonfetal4 reports
- NATUS NEUROLOGY XMD008Natus Neurology Incorporated · Monitor, Ultrasonic, Nonfetal1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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