Natus 515-005500Recalls & reported problems
Natus Neurology Incorporated · Cortical Stimulator Control Unit · 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 00382830041799), received between Mar 21, 2025 and Mar 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Software Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K060421); 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.
Reports received per month
Most reported problems
Device problems
- Computer Software Problem1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2025Computer Software Problem; Connection Problem; Computer Software Problem; Connection Problem
PART 515-005500F - ERROR MESSAGE REGARDING DSM CONTROL ISSUE/INTERNET DURING EMU MONITORING. PROCEDURE AT THE TIME WAS SURGICAL EEG PLACEMENT AND EMU ADMISSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662396 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K060421. One submission often covers many models, so check the product and lot details in each record.
- Z-0999-2009 · Jan 6, 2009 · TerminatedViasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0470 Sonara Bilateral. The Sonara Transcranial Doppler system is a medical ult
- Z-0998-2009 · Jan 6, 2009 · TerminatedViasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. The Sonara Transcranial Doppler system is a medical ul
Other System, Imaging, Pulsed Doppler, Ultrasonic devices
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- EPIQ 7 Diagnostic Ultrasound System 989605386721Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls2 deaths146 reports
- Transducer S7-3t 989605406772Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic5 recalls1 death18 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · System, imaging, pulsed doppler, ultrasonic199 reports
- Transducer S7-3t 989605439232Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls4 reports
- Transducer 3D9-3v 989605395622Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls1 report
- ACUSON Redwood Diagnostic Ultrasound System 11503314Siemens Medical Solutions USA, Inc. · System, imaging, pulsed doppler, ultrasonic3 recalls0 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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