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GN Otometrics A/S Aurical FreeFit, Complete SolutionRecalls & reported problems

Natus Medical Denmark ApS · 1053 FreeFit Module · Class 2

All models of GN Otometrics A/S (6)

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 05713315004117), received between Mar 17, 2022 and Mar 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Incompatible” (1 report).

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

  • Component Incompatible1
  • Melted1

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 17, 2022Component Incompatible; Melted; Component Incompatible

    AURICAL CAN'T TURN ON - OTOAIR MELTED. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. NO INJURIES REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13791961 ↗

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Sources and updates

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