NATUS NEUROLOGY XMD008Recalls & reported problems
Natus Neurology Incorporated · ELITE AUTO SHUT-OFF 200R MAIN · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382830028042), received between Dec 23, 2019 and Dec 23, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Sensing Problem” (1 report).
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 Problem1
- Environmental Compatibility Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2019Device Sensing Problem; Environmental Compatibility Problem; Device Sensing Problem; Environmental Compatibility Problem
NOISE PREVENTS USER FROM BEING ABLE TO HEAR FETAL HEARTBEAT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9512785 ↗
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-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-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
- 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-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
Other Monitor, Ultrasonic, Nonfetal devices
- NATUS NEUROLOGY X1L001Natus Neurology Incorporated · Monitor, Ultrasonic, Nonfetal39 reports
- NATUS NEUROLOGY X1L004Natus Neurology Incorporated · Monitor, Ultrasonic, Nonfetal4 reports
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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